Bioequivalency Study of Zidovudine Under Fasting Conditions

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT00602550
• Lead Sponsor: Roxane Laboratories

Brief Summary

The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-01-28
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory findings during screening.

Exclusion Criteria

• Allergic or adverse responses to zidovudine or any other comparable or similar products.
• Participation in clinical trial within 30 days of study initiation.
• Positive blood screen for HIV, Hepatitis B and C.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bioequivalence	Baseline, Two period, Three day washout

Trial Locations

Locations (1)

CEDRA Clinical Research; 🇺🇸 Austin, Texas, United States