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Bioequivalence Study of Clorazepate Dipotassium 15mg Tablets Under Fasting Conditions
This study has been completed.
First Received: October 17, 2008   No Changes Posted
Sponsored by: Ranbaxy Laboratories Limited
Information provided by: Ranbaxy Inc.
ClinicalTrials.gov Identifier: NCT00775996
  Purpose

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
Healthy
Drug: Clorazepate Dipotassium 15mg Tablets

Drug Information available for: Clorazepate Clorazepate dipotassium
U.S. FDA Resources
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.

Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

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
1: Experimental
15 mg clorazepate dipotassium tablets of ranbaxy
Drug: Clorazepate Dipotassium 15mg Tablets
2: Active Comparator
(TranxeneeT-Tab®) 15 mg clorazepate dipotassium tablets
Drug: Clorazepate Dipotassium 15mg Tablets

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects were only included in the study if they met all of the following criteria:

    1. Healthy adult male or female volunteers, 18-55 years of age
    2. Weighing at least 60 kg for males and 52 kg for females and within 15% of their ideal weights
    3. (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983); Medically healthy subjects with clinically normal laboratory profiles and ECGs as deemed by the principal investigator;
    4. 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:

      • surgically sterile (bilateral ligation, hysterectomy, bilateral oophorectomy) 6 months minimum;
      • IUD in place for at least 3 months;
      • barrier methods (condom, diaphragm) with spermicide from the time of last menstrual period and throughout the study;
      • surgical sterilization of the partner (vasectomy for 6 months minimum);
      • hormonal contraceptives for at least 3 months prior to the first dose of the study. Postmenopausal women with amenorrhea for at least 1 year, and confirmed by blood testing (FSH levels > 40 international units/mL).
  • Voluntarily consent to participate in the study,

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:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
  • In addition, history or presence of:

    • alcoholism or drug abuse;
    • seizures;
    • g1aucoma;
    • hypersensitivity or idiosyncratic reaction to any drug, especially clorazepate or benzodiazepines.
  • Female subjects who are pregnant or lactating.
  • Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
  • Subjects who have made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to the first dose.
  • Subjects who have made a plasma donation within 7 days prior to the first dose.
  • Subjects who have participated in another clinical trial within 28 days prior to the first dose.
  • Subjects with hemoglobin less than 12_0 g/dL.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775996

Locations
United States, Nebraska
MDS Pharma Services
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

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

Keywords provided by Ranbaxy Inc.:
bioequivalence Clorazepate Tablets

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants
Anti-Anxiety Agents
Healthy
Clorazepate Dipotassium
Anticonvulsants

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009