Bioequivalency Study of Zidovudine Under Fed Conditions

Roxane Laboratories

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Zidovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00601562

ZIDO-04

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 fed 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 the physical examination, medical history, or clinical laboratory results during screening.

Exclusion criteria

• Participation in a clinical trial within 30 days prior to study initiation.
• Positive blood screen for HIV or Hepatitis B and C.
• History of allergic or adverse responses to zidovudine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)