NCT00775996

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2003

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
Last Updated

October 20, 2008

Status Verified

October 1, 2008

Enrollment Period

1 month

First QC Date

October 17, 2008

Last Update Submit

October 17, 2008

Conditions

Healthy

Keywords

bioequivalence Clorazepate Tablets

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence

Study Arms (2)

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

Interventions

Clorazepate Dipotassium 15mg TabletsDRUG
12

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects were only included in the study if they met all of the following criteria:
  • Healthy adult male or female volunteers, 18-55 years of age
  • Weighing at least 60 kg for males and 52 kg for females and within 15% of their ideal weights
  • (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;
  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDS Pharma Services

Lincoln, Nebraska, 68502, United States

Location

Related Links

MeSH Terms

Interventions

Clorazepate Dipotassium

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 17, 2008

First Posted

October 20, 2008

Study Start

August 1, 2003

Primary Completion

September 1, 2003

Study Completion

November 1, 2003

Last Updated

October 20, 2008

Record last verified: 2008-10

Locations

US(1)