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Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT00779376
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : October 24, 2008
Sponsor:
Information provided by:
Ranbaxy Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Zidovudine 300mg tablets Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : February 2005
Actual Primary Completion Date : March 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
Drug Information available for: Zidovudine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Zidovudine 300mg tablets of Ranbaxy
Drug: Zidovudine 300mg tablets
Active Comparator: 2
Retrovir ®) 300 mg Zidovudine tablets of Glaxosmithkline
Drug: Zidovudine 300mg tablets



Primary Outcome Measures :
  1. Bioequivalence


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult male or female volunteers, 18-55 years of age
  2. 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)
  3. Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs
  4. 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

  5. Postmenopausal women with amenorrhea for at least 2 years
  6. Given voluntary written informed consent to participate in this study.

Exclusion Criteria:

  1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease
  2. 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
  3. Female subjects who were pregnant or lactating
  4. Subjects who tested positive at screening for HIV, HBsAg or HCV
  5. 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
  6. 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
  7. 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
  8. Subjects who have participated in another clinical trial within 28 days prior to the first dose.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779376


Locations
Canada, Quebec
MDS Pharma Services
Montreal, Quebec, Canada, H4R2N6
Sponsors and Collaborators
Ranbaxy Laboratories Limited

Additional Information:
Responsible Party: Dr. Tausif Monif, Ranbaxy Research Labs
ClinicalTrials.gov Identifier: NCT00779376     History of Changes
Other Study ID Numbers: AA26101
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: October 24, 2008
Last Verified: October 2008

Keywords provided by Ranbaxy Inc.:
Bioequivalence

Additional relevant MeSH terms:
Zidovudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents