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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT01167933
Brief Summary:
The purpose of this study is to
* compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg tablets of MercK \& Co. Inc, USA in healthy subjects under fed conditions
* monitor adverse events and to ensure the safety of subjects.
Detailed Description:
A randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study of Simvastatin 80 mg tablets of Dr. Reddy's Laboratories Limited to be compared with Zocor® 80 mg tablets of Merck \& Co. Inc., USA in healthy, adult, human subjects under fed conditions.
Study:
NCT01167933
Study Brief:
Protocol Section:
NCT01167933