Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fed Conditions - Full Text View

Sponsored by:	Ranbaxy Laboratories Limited
Information provided by:	Ranbaxy Inc.
ClinicalTrials.gov Identifier:	NCT00779376

Purpose

The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy and GlaxoSmithKline (Retrovir ®) 300 mg Zidovudine tablets, under fed conditions

Condition	Intervention
Healthy	Drug: Zidovudine 300mg tablets

Drug Information available for: Zidovudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Official Title:	Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Ranbaxy and GlaxoSmithKline (Retrovir ® ) 300 mg Zidovudine Tablets in Healthy Adult Volunteers Under Fed Conditions

Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:

Bioequivalence [ Designated as safety issue: No ]

Enrollment:	68
Study Start Date:	February 2005
Study Completion Date:	April 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Zidovudine 300mg tablets of Ranbaxy	Drug: Zidovudine 300mg tablets
2: Active Comparator Retrovir ®) 300 mg Zidovudine tablets of Glaxosmithkline	Drug: Zidovudine 300mg tablets

Detailed Description:

This was an open label, randomized, single dose, 2-way crossover, comparative bioavailability study performed on 68 healthy adult volunteers. In each period, subjects were housed from at least 10 hours before dosing until after the 12 hour blood draw. Single oral dose 300 mg Zidovudine doses were separated by a washout period of 7 days.

A total of sixty-eight (68) healthy adult subjects (29 males and 39 females) were enrolled in the study, of which sixty five (65) subjects (29 males and 36 females) completed the clinical portion of the study.

Eligibility

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

Criteria

Inclusion Criteria:

Healthy adult male or female volunteers, 18-55 years of age
Weighing at least 52 kg for males and 45 kg for females 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, vital signs and ECGs
Females of child bearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or were using one of the following acceptable birth control methods:

Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum; IUD in place for at least 3 months; Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study Surgical sterilization of the partner (vasectomy for 6 months minimum) Hormonal contraception for at least 3 months prior to the first dose of the study Other birth control method deemed acceptable
Postmenopausal women with amenorrhea for at least 2 years
Given voluntary written informed consent to participate in this study.

Exclusion Criteria:

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 within the past year, or hypersensitivity or idiosyncratic reaction to Zidovudine or to any other nucleoside analogue
Female subjects who were pregnant or lactating
Subjects who tested positive at screening for HIV, HBsAg or HCV
Subjects who have used any drugs or substances known to be strong inhibitors of cyp enzymes (formerly known as cytochrome p 450 enzymes) within 10 days prior to the first dose
Subjects who have used any drugs or substances known to be strong inducers of cyp enzymes (formerly known as cytochrome P 450 enzymes) within 28 days prior to the first dose and throughout the study
Subjects who through completion of the study would have donated in excess of 500 mL of blood in 14 days, 1500 mL of blood in 180 days or 2500 mL of blood in 1 year
Subjects who have participated in another clinical trial within 28 days prior to the first dose.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779376

Locations

Canada, Quebec
MDS Pharma Services
Montreal, Quebec, Canada, H4R2N6

Sponsors and Collaborators

Ranbaxy Laboratories Limited

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Ranbaxy Research Labs ( Dr. Tausif Monif )
Study ID Numbers:	AA26101
Study First Received:	October 23, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00779376
Health Authority:	Canada: Health Canada

Keywords provided by Ranbaxy Inc.:

Bioequivalence

Study placed in the following topic categories:

Malnutrition
Zidovudine
Healthy

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Antiviral Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009