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- Register voor klinische proeven in de VS.
- Klinische proef NCT00776620
Bioequivalence Study of Glimepiride 1mg Tablets Under Fed Conditions
A Relative Bioavailability Study of Glimepiride 1 MG Tablets Under Fed Conditions
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on glimepiride comparing glimepiride 1mg tablets of Ranbaxy laboratories limited with Amaryl 1mg tablets of in healthy, adult, human, subjects under fed conditions.
Thirty-two (32) subjects were recruited for this study and all subjects were healthy adults. Thirty-two (32) subjects began the study, and thirty-two (32) completed the clinical portion of the study.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Texas
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Houston, Texas, Verenigde Staten, 77042
- Novum Pharmaceutical Research Services
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Source of Subjects: Non-institutionalized subjects consisting of members of the community at large.
Characterization of Study Group.
- All subjects selected for this study will be at least 18 years of age.
- Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.
- Each female subject will be given a serum pregnancy test as part of the pre-study screening process. At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements. Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.
Clinical laboratory measurements will include the following:
- Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood cell count (with differential).
- Clinical Chemistry: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and alkaline phosphatase.
- Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells.
- HIV Screen:(pre-study only)
- Hepatitis-B, C Screen:(pre-study only)
- Drugs of Abuse Screen:pre-study and at check-in each study period
- Subjects will be selected if all above are normal.
- Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.
Exclusion Criteria:
- Subjects with a history of chronic alcohol consumption I,(during past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease,tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
- Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
- Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study. d. All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
- Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
- Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
- Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate.
- Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g.condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate.
- Subjects who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study dosing, or used oral hormonal contraceptives within 14 days before dosing will not be allowed to participate.
- All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or Inconclusive results will be withdrawn from the study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 1
Glimepiride 1 MG Tablets of Ranbaxy
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Actieve vergelijker: 2
AMARYL® 1 mg tabletten
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Bio-equivalentie
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 10381502
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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