Bioequivalence Study of Clorazepate Dipotassium 15mg Tablets Under Fasting Conditions
Information source: Ranbaxy Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Clorazepate Dipotassium 15mg Tablets (Drug)
Phase: N/A
Status: Completed
Sponsored by: Ranbaxy Laboratories Limited
Summary
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Bioequivalence
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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
MDS Pharma Services, Lincoln, Nebraska 68502, United States
Additional Information
Starting date: August 2003
Last updated: October 17, 2008
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