- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03150082
Bioequivalence Study Between GR37547 500 Milligrams (mg) Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Subjects
27 giugno 2018 aggiornato da: GlaxoSmithKline
An Open-label, Randomised, Single-dose, Two-period Cross-over Study to Evaluate Bioequivalence of GR37547 Ciprofloxacin 500 mg Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Participants Under Fasting Conditions
This two-period cross-over study will evaluate bioequivalence of GR37547 (ciprofloxacin 500 mg) tablet versus ciprofloxacin 500 mg reference tablet in healthy adult subjects under fasting conditions.
Subjects will receive Treatment A (GR37547 tablet) and Treatment B (ciprofloxacin reference tablet) in crossover manner, separated by a washout period of at least 7 days and not more than 14 days.
The total duration of study for each subject will be approximately 5-7 weeks.
This study will enroll approximately 26 healthy adult subjects at a single center.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
26
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Bloemfontein,, Sud Africa, 9301
- GSK Investigational Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 60 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Subject must be between 18 and 60 years of age inclusive, at the time of signing the informed consent.
- Healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the normal reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required,agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight >=50 kilogram (kg) and body mass index (BMI) within the range 19-30 kg per meter square (kg/m^2) (inclusive).
- Healthy Male or female subjects: Male subjects: A male subject must agree to use contraception during the treatment period and for at least 5 days, after the last dose of study treatment and refrain from donating sperm during this period; Female subjects: A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment.
- The investigator is responsible for ensuring that male and female study subjects understand how to correctly use the methods of contraception.
- Capable of giving signed informed consent.
Exclusion Criteria:
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neuromuscular, psychiatric, auto-immune or neurological disorders.
- History of convulsions.
- Any other condition that is capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
- History of any malignancies or chemotherapy/radiation within the past 5 years excluding treated squamous carcinoma of the skin and adequately excised basal cell carcinoma.
- History of kidney, heart or lung transplants.
- History or presence of rheumatoid arthritis.
- Presence of hypocalcaemia where the serum potassium is < lower limit of normal (LLN).
- Presence of hypomagnesaemia where the serum magnesium is < LLN.
- Fasting blood glucose >=7 millimoles (mmol)/liter (L).
- Serum glucose-6-phosphate dehydrogenase < LLN.
- Abnormal renal function, as determined by creatinine clearance and considered as clinically significant by the investigator will be excluded.
- Alanine transaminase (ALT) >1.5x upper limit of normal (ULN).
- Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Excessive alkalinity of the urine (potential of hydrogen [pH] >=9), as determined on Day -1.
- Abnormal BP as determined by the investigator.
- QT interval corrected for heart rate according to Bazett's formula (QTcB) >450 milliseconds (msec). Subjects with a known risk of QT prolongation will be excluded. For purposes of data analysis, only QTcB, will be used
- Past or intended use of over-the-counter or prescription medication including herbal medications, within 14 days prior to dosing unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
- Where participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 90 days.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Current enrolment or past participation within the last 90 days before signing of consent in this or any other clinical study involving an investigational study treatment.
- Presence of Hepatitis B surface antigen (HBsAg) at screening or a Positive Hepatitis C antibody test result at screening.
- Positive pre-study drug/alcohol screen.
- Positive human immunodeficiency virus (HIV) antibody test.
- Regular use of known drugs of abuse.
- Sensitivity to heparin or heparin-induced thrombocytopenia.
- Sensitivity to any of the study treatments, or components thereof, or drug or other allergy including allergy to quinolones that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
- Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco or nicotine-containing products within 6 months prior to screening.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Treatment sequence: A/B
Eligible subjects will be randomized to receive a single dose of Treatment A (GR37547 500 mg tablet) followed by Treatment B (ciprofloxacin 500 mg reference tablet) administered orally on Day 1 in each treatment period.
The washout period will be of at least 7 days and not more than 14 days.
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A single tablet of GR37547 should be taken orally with 240 mL of water.
GR37547 500 mg tablet will be a white to off white capsule shape with break line on upper side and embossed "GSK500"on lower side.
A single tablet of ciprofloxacin reference should be taken orally with 240 mL of water.
Ciprofloxacin 500 mg reference will be nearly white to slightly yellowish film coated oblong tablets with break line and ''CIP 500" marked on upper side and "BAYER" on lower side.
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Sperimentale: Treatment sequence: B/A
Eligible subjects will be randomized to receive a single dose of Treatment B (ciprofloxacin 500 mg reference tablet) followed by Treatment A (GR37547 500 mg tablet) administered orally.
The washout period will be of at least 7 days and not more than 14 days.
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A single tablet of GR37547 should be taken orally with 240 mL of water.
GR37547 500 mg tablet will be a white to off white capsule shape with break line on upper side and embossed "GSK500"on lower side.
A single tablet of ciprofloxacin reference should be taken orally with 240 mL of water.
Ciprofloxacin 500 mg reference will be nearly white to slightly yellowish film coated oblong tablets with break line and ''CIP 500" marked on upper side and "BAYER" on lower side.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-t]) for Ciprofloxacin
Lasso di tempo: Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
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Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state.
Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.
Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.
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Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
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Maximum Observed Plasma Concentration (Cmax) of Ciprofloxacin
Lasso di tempo: Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
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Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state.
Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.
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Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for Ciprofloxacin
Lasso di tempo: Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
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Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state.
Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.
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Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
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Time of Occurrence of Cmax (Tmax) for Ciprofloxacin
Lasso di tempo: Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
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Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state.
Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.
Tmax of ciprofloxacin was analyzed using a nonparametric test to compute point estimate of the median and full range.
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Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
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Percentage of AUC (0-infinity) Obtained by Extrapolation (Percentage AUCex) for Ciprofloxacin
Lasso di tempo: Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
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Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state.
Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.
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Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
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Terminal Phase Half-life (t1/2) for Ciprofloxacin
Lasso di tempo: Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
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Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state.
Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.
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Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
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Number of Participants With Serious Adverse Events (SAEs) and Non-serious AEs (Non-SAEs)
Lasso di tempo: Up to 4 weeks in each treatment period
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations.
The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
Participants were analyzed according to the treatment they actually received.
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Up to 4 weeks in each treatment period
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Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, Alk phos, AST and LD.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Blood Urea Nitrogen (BUN) at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, chloride, glucose, magnesium, potassium and sodium.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Total Protein at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Mean Corpuscular Volume (MCV) at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Percent Reticulocytes at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Hematocrit at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Erythrocyte Count at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Number of Participants With Clinically Significant Abnormal Findings for Urinalysis
Lasso di tempo: Up to Day 2 of each treatment period
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Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. The number of participants with abnormal (clinically significant) findings for urinalysis have been presented.
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Up to Day 2 of each treatment period
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Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters
Lasso di tempo: Up to Day 2 of each treatment period
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A single 12-lead ECGs was obtained on Day 1 and Day 2 of each treatment period 1 and 2 using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals.
The number of participants with abnormal (clinically significant) findings for ECG parameters have been presented.
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Up to Day 2 of each treatment period
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Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Respiratory Rate at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Pulse Rate at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Body Temperature at Indicated Time-points
Lasso di tempo: Up to Day 2 of each treatment period
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Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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Up to Day 2 of each treatment period
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 agosto 2017
Completamento primario (Effettivo)
28 agosto 2017
Completamento dello studio (Effettivo)
28 agosto 2017
Date di iscrizione allo studio
Primo inviato
10 maggio 2017
Primo inviato che soddisfa i criteri di controllo qualità
10 maggio 2017
Primo Inserito (Effettivo)
11 maggio 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 dicembre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 giugno 2018
Ultimo verificato
1 giugno 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni
- Infezioni batteriche e micosi
- Infezioni batteriche
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Inibitori enzimatici
- Agenti antineoplastici
- Inibitori della topoisomerasi II
- Inibitori della topoisomerasi
- Agenti antibatterici
- Inibitori dell'enzima del citocromo P-450
- Inibitori del citocromo P-450 CYP1A2
- Ciprofloxacina
Altri numeri di identificazione dello studio
- 205730
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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