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

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00779233
First received: October 23, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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 Intervention
Healthy
Drug: Zidovudine tablets 300 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: September 2004
Study Completion Date: October 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779233

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

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Labs
ClinicalTrials.gov Identifier: NCT00779233     History of Changes
Other Study ID Numbers: 10440303
Study First Received: October 23, 2008
Last Updated: October 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:
Bioequivalence

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

ClinicalTrials.gov processed this record on July 24, 2014