Bioequivalency Study of Zidovudine Under Fed 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 fed 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 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.

Locations (1)

CEDRA Clinical Research, LLC

Austin, Texas, United States

Outcomes

Primary Outcomes

Bioequivalence

Time frame: Baseline, Two period, Three day washout

Data from ClinicalTrials.gov

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