Bioequivalency Study of Zidovudine Under Fed Conditions

HIV Infections Clinical Trial

Official title:

A Single Dose, Two Treatment, Two Period, Two Sequence, Crossover Bioequivalency Study of 300 mg Zidovudine Tablets Under Fed Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601562
• Other study ID #: ZIDO-04
• Status: Completed
• Phase: N/A
• First received: September 19, 2007
• Last updated: January 19, 2018
• Start date: June 2003
• Est. completion date: June 2003

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Zidovudine

Locations

Country	Name	City	State
United States	CEDRA Clinical Research, LLC	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence		Baseline, Two period, Three day washout