Bioequivalency Study of Zidovudine Under Fasting Conditions

Roxane Laboratories52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

ZidovudineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CEDRA Clinical Research

Austin, Texas, United States

Outcomes

Primary Outcomes

Bioequivalence

Time frame: Baseline, Two period, Three day washout

Data from ClinicalTrials.gov

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