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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00779233
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : October 24, 2008
Information provided by:
Ranbaxy Inc.

Brief Summary:
The purpose of this study is to evaluate the relative bioavailability of the test formulation of Zidovudine 300 mg tablets with an already marketed reference formulation RETROVIR ® 300 mg tablets (GlaxoSmithKline), under fasted conditions in healthy male and female adult subjects.

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

Detailed Description:

A randomized, single dose, two way crossover study was conducted with up to 32 healthy, male and female adult subjects to compare two Zidovudine 300 mg tablet formulations under fasting conditions.

In each period one x 300 mg tablet was administered to fasting subjects. Subjects received the test product in one study period and the reference product in the other period. The order of the treatment administration was as per the dosing randomization schedule. Each dose was separated by at least a 7 day interval.

A total of thirty two (32) subjects (23 males and 9 females) were enrolled for the study, of which only twenty eight (28) subjects completed the clinical portion of the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Study to Compare the Relative Bioavailability of Ranbaxy and GlaxoSmithKline Formulation of Zidovudine Tablets 300 mg in Healthy Adult Volunteers Under Fasting Conditions.
Study Start Date : September 2004
Actual Primary Completion Date : September 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Zidovudine

Arm Intervention/treatment
Experimental: 1
Zidovudine tablets 300 mg of Ranbaxy
Drug: Zidovudine tablets 300 mg
Active Comparator: 2
RETROVIR ® 300 mg tablets (GlaxoSmithKline)
Drug: Zidovudine tablets 300 mg

Primary Outcome Measures :
  1. Bioequivalence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Males and females, 18 to 65 years of age, inclusive with a body mass index (BMI) in the range 18-30 kg/m2 inclusive, measured according to Novum Standard operating Procedures
  2. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and during the duration of the study
  3. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening
  4. Signed and dated informed consent form, which meets all criteria of current FDA regulations

Exclusion Criteria:

  1. If female, pregnant, lactating or likely to become pregnant during the study
  2. History of allergy or sensitivity to Zidovudine, or other antiviral or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study
  3. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction
  4. Presence of gastrointestinal disease or history of malabsorption within the last year
  5. History of psychiatric disorders occurring within the last two years that required hospitalization or medication
  6. Presence of a medical condition requiring regular treatment with prescription drugs (other than contraceptives)
  7. Use of pharmacologic agents known to significantly induce or inhibit drug metabolizing enzymes within 30 days prior to dosing
  8. Receipt of any drug as part of research study within 30 days prior to dosing.
  9. Drug or alcohol addiction requiring treatment in the past 12 months
  10. Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing
  11. Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody
  12. Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody
  13. Positive test results for drugs of abuse at screening
  14. Positive serum pregnancy test

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 identifier (NCT number): NCT00779233

United States, Nevada
Novum Pharmaceutical Research Services
Las Vegas, Nevada, United States, 89121
Sponsors and Collaborators
Ranbaxy Laboratories Limited

Additional Information:
Responsible Party: Dr. Tausif Monif, Ranbaxy Research Labs Identifier: NCT00779233     History of Changes
Other Study ID Numbers: 10440303
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: October 24, 2008
Last Verified: October 2008

Keywords provided by Ranbaxy Inc.:

Additional relevant MeSH terms:
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