Expired Study
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Austin, Texas 78759


Purpose:

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.


Criteria:

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.


Study is Available At:


Original ID:

ZIDO-03


NCT ID:

NCT00602550


Secondary ID:


Study Acronym:


Brief Title:

Bioequivalency Study of Zidovudine Under Fasting Conditions


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

West-Ward Pharmaceutical


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

52


Enrollment Type:

Actual


Overall Contact Information

Official Name:Daniel V Freeland, DO
Principal Investigator
CEDRA Clinical Research

Study Dates

Start Date:June 2003
Completion Date:June 2003
Completion Type:Actual
Primary Completion Date:June 2003
Primary Completion Type:Actual
Verification Date:January 2018
Last Changed Date:January 19, 2018
First Received Date:September 19, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Bioequivalence
Time Frame:Baseline, Two period, Three day washout
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Zidovudine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Roxane Laboratories

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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