Bioequivalency Study of Zidovudine Under Fed Conditions

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00601562

Run by

Roxane Laboratories

People needed

52

Starts

2003-06-01

Expected to finish

2003-06-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

You may not qualify if…

• 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.

Where it is running

• CEDRA Clinical Research, LLC — Austin, Texas, United States

Full record on ClinicalTrials.gov

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