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

A Study to Compare the Relative Bioavailability of Ranbaxy and GlaxoSmithKline Formulation of Zidovudine Tablets 300 mg in Healthy Adult Volunteers Under Fasting Conditions.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Novum Pharmaceutical Research Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalence

Collaborators and Investigators

• Sponsor: Ranbaxy Laboratories Limited

Publications and helpful links

Helpful Links

• Related Info
• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (ACTUAL): September 1, 2004
• Study Completion (ACTUAL): October 1, 2004

Study Registration Dates

• First Submitted: October 23, 2008
• First Submitted That Met QC Criteria: October 23, 2008
• First Posted (ESTIMATE): October 24, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 24, 2008
• Last Update Submitted That Met QC Criteria: October 23, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Bioequivalence
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Zidovudine
• Other Study ID Numbers: 10440303