Bioequivalency Study of Zidovudine Under Fasting Conditions

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Roxane Laboratories
• Treatments: Zidovudine

Criteria

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.