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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00775996 |
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Abbott (TranxeneeT-Tab®) 15 mg clorazepate dipotassium tablets under fasting conditions.
Condition | Intervention |
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Healthy |
Drug: Clorazepate Dipotassium 15mg Tablets |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | The Objective of This Study Was to Compare the Single-Dose Relative Bioavailability of Ranbaxy and Abbott (Tranxene® T-Tab®) 15 mg Clorazepate Dipotassium Tablets Under Fasting Conditions. |
Enrollment: | 32 |
Study Start Date: | August 2003 |
Study Completion Date: | November 2003 |
Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
15 mg clorazepate dipotassium tablets of ranbaxy
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Drug: Clorazepate Dipotassium 15mg Tablets |
2: Active Comparator
(TranxeneeT-Tab®) 15 mg clorazepate dipotassium tablets
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Drug: Clorazepate Dipotassium 15mg Tablets |
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on clorazepate dipotassium comparing clorazepate dipotassium 15mg tablets of Ranbaxy Laboratories with Abbott (TranxeneeT-Tab®) 15 mg, in healthy, adult, human, subjects under fasting conditions. A total of 32 subjects, 25 males and 7 females, were enrolled in the study, and 31 subjects, 24 males and 7 females, completed the study.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects were only included in the study if they met all of the following criteria:
Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
Exclusion Criteria:
Subjects were excluded from the study if there was evidence of any of the following at screening or at any time during the study:
In addition, history or presence of:
Responsible Party: | Ranbaxy Research Laboratories ( Dr. Tausif Monif ) |
Study ID Numbers: | AA06461 |
Study First Received: | October 17, 2008 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00775996 History of Changes |
Health Authority: | United States: Institutional Review Board |
bioequivalence Clorazepate Tablets |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Central Nervous System Depressants |
Anti-Anxiety Agents Healthy Clorazepate Dipotassium Anticonvulsants |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Pharmacologic Actions Therapeutic Uses GABA Agents Anti-Anxiety Agents Clorazepate Dipotassium Central Nervous System Agents Anticonvulsants |