- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00602589
A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects
An Open-label, Randomized, 3-way Crossover Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
In this single-dose study conducted at at single center, 3 oral formulations of levofloxacin (tablet, suspension, and solution) were assessed for their bioequivalence in healthy men and women aged 18 to 55 years old. Subjects were assigned different treatments based on chance; both the researcher and the study participant knew the treatment being administered. The study consisted of a screening period, 3 open-label treatment periods separated by washout periods of at least 4 days between doses, and a post-treatment period. Subjects received a single dose of all 3 study formulations, administered as a single dose of each formulation on Day 1 of each treatment period. Blood samples were collected on Days 1, 2, and 3 of each treatment period immediately before dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 10, 14, 24, 30, 36, and 48 hours after dosing for measurement of levofloxacin concentration. Subjects were admitted to the study site prior to dosing and remained through the 48-hour measurements on Day 3. The post-treatment period included physical examination and clinical laboratory testing to ensure subject safety before being discharged from the study. Safety evaluations, including adverse event monitoring, standard clinical laboratory evaluations (hematology, serum chemistry, and urinalysis), vital sign monitoring, and physical examinations, were monitored throughout the study.
Two cohorts of 36 subjects each were enrolled in the study. The first cohort received a single dose of study drug and completed Period 1; the study was then stopped and reinitiated. Subjects from the first cohort completed early termination procedures; their data were included in safety analyses, however, no blood samples for levofloxacin concentrations were analyzed or included in pharmacokinetic analysis. Thirty-four subjects in the second cohort completed all study procedures. Levofloxacin oral suspension (125 mg/5 mL), levofloxacin oral solution (125 mg/5 mL), and levofloxacin tablet (500 mg) administered on Day 1 of each treatment period.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Men and women
- Aged 18 to 55 years
- BMI between 18 and 30 kg/m2
- No prescription or over-the-counter medications for previous 14 days
- Negative tests for drug and alcohol abuse, HIV, hepatitis B and hepatitis C
- and Healthy based on medical history, physical examination, 12-lead electrocardiograms, toxicology, antigen, and antibody screens, and clinical laboratory evaluations
Exclusion Criteria:
- Allergic reaction to quinolones
- Clinically significant ECG or clinical laboratory abnormalities
- Creatinine clearance <=80 mL/min
- Acute illness within 7 days
- Nicotine use within 1 year
- Receipt of experimental drug or device within 60 days
- Pregnant or breastfeeding
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
---|
Assessment of the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, on Days 1, 2, and 3, using the marketed tablet as the reference.
|
Sekundära resultatmått
Resultatmått |
---|
Assessment of the bioequivalence of the oral suspension and solution formulations, on Days 1, 2, and 3, using the suspension formulation as the reference.
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Enzyminhibitorer
- Antineoplastiska medel
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Antibakteriella medel
- Cytokrom P-450 enzymhämmare
- Cytokrom P-450 CYP1A2-hämmare
- Anti-infektionsmedel, urinvägar
- Njurmedel
- Levofloxacin
- Ofloxacin
Andra studie-ID-nummer
- CR011395
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