Bioequivalency Study of Zidovudine Under Fasting Conditions

Roxane Laboratories

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Zidovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00602550

ZIDO-03

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)