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Bioequivalency Study of Zidovudine Under Fed Conditions

Roxane Laboratories logo

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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