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Sponsored by: |
Ranbaxy Laboratories Limited |
---|---|
Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00779233 |
The purpose of this study is to evaluate the relative bioavailability of the test formulation of Zidovudine 300 mg tablets with an already marketed reference formulation RETROVIR ® 300 mg tablets (GlaxoSmithKline), under fasted conditions in healthy male and female adult subjects.
Condition | Intervention |
---|---|
Healthy |
Drug: Zidovudine tablets 300 mg |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Study to Compare the Relative Bioavailability of Ranbaxy and GlaxoSmithKline Formulation of Zidovudine Tablets 300 mg in Healthy Adult Volunteers Under Fasting Conditions. |
Enrollment: | 32 |
Study Start Date: | September 2004 |
Study Completion Date: | October 2004 |
Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Zidovudine tablets 300 mg of Ranbaxy
|
Drug: Zidovudine tablets 300 mg |
2: Active Comparator
RETROVIR ® 300 mg tablets (GlaxoSmithKline)
|
Drug: Zidovudine tablets 300 mg |
A randomized, single dose, two way crossover study was conducted with up to 32 healthy, male and female adult subjects to compare two Zidovudine 300 mg tablet formulations under fasting conditions.
In each period one x 300 mg tablet was administered to fasting subjects. Subjects received the test product in one study period and the reference product in the other period. The order of the treatment administration was as per the dosing randomization schedule. Each dose was separated by at least a 7 day interval.
A total of thirty two (32) subjects (23 males and 9 females) were enrolled for the study, of which only twenty eight (28) subjects completed the clinical portion of the study.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Ranbaxy Research Labs ( Dr. Tausif Monif ) |
Study ID Numbers: | 10440303 |
Study First Received: | October 23, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00779233 |
Health Authority: | United States: Institutional Review Board |
Bioequivalence |
Zidovudine Healthy |
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