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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT01603134
Brief Summary:
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over comparative pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human male subjects.
Detailed Description:
Objective of this pivotal study was to assess the bioequivalence between Test Product: Allopurinol 300 mg Tablets USP of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Zyloprim® (Allopurinol) 300 mg Tablets manufactured by Catalytica Pharma Inc., USA for Prometheus Laboratories Inc., USA, under fasting condition in normal, healthy, adult, human male subjects in a randomized crossover study.
The study was conducted with 32 healthy adult male subjects. In each study period, a single 300 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 51 days including washout period of at 18 days between administrations of study drug in each study period.
Study:
NCT01603134
Study Brief:
Protocol Section:
NCT01603134