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:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT01884857
Brief Summary:
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy adult human subjects.
Detailed Description:
Objective of this pivotal study was to assess the bioequivalence between Test Product: Metoprolol Succinate 50 mg Ipca Laboratories Limited, India and the corresponding Reference Product: TOPROL-XL® (Metoprolol Succinate) extended release Tablets 50 mg of Astrazenica LP, USA under fasting condition in healthy adult human subjects in a randomized crossover study.
The study was conducted with 48 healthy adult subjects. In each study period, a single 50 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.
The duration of the clinical phase was approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period.
Study:
NCT01884857
Study Brief:
Protocol Section:
NCT01884857