Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT00779233
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT00779233
Study Brief:
Protocol Section:
NCT00779233