Bioequivalence Study of Clorazepate Dipotassium 15mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00775996
First received: October 17, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted

October 17, 2008
October 17, 2008
August 2003
September 2003   (final data collection date for primary outcome measure)
Bioequivalence [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioequivalence Study of Clorazepate Dipotassium 15mg Tablets Under Fasting Conditions
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
Drug: Clorazepate Dipotassium 15mg Tablets
  • Experimental: 1
    15 mg clorazepate dipotassium tablets of ranbaxy
    Intervention: Drug: Clorazepate Dipotassium 15mg Tablets
  • Active Comparator: 2
    (TranxeneeT-Tab®) 15 mg clorazepate dipotassium tablets
    Intervention: Drug: Clorazepate Dipotassium 15mg Tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 2003
September 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00775996
AA06461
Yes
Dr. Tausif Monif, Ranbaxy Research Laboratories
Ranbaxy Laboratories Limited
Not Provided
Not Provided
Ranbaxy Inc.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP