NCT01722110

Bioequivalence Study of Indomethacin Extended-Release Capsules 75 mg Under Fed Condition

A Randomized, Balanced, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Indomethacin Extended-Release Capsules 75 mg of Ipca Laboratories Ltd., With Indomethacin Extended-Release Capsules USP 75 mg of Epic Pharma, USA, in Normal, Healthy, Adult, Male and Female Human Subjects Under Fed Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: IPCA Laboratories Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal, healthy, adult, male and female human subjects.

Detailed description

Objective of this pivotal study was to assess the bioequivalence between Test Product: Indomethacin Extended-Release Capsules USP 75 mg of Ipca Laboratories Limited, India and the corresponding Reference Product: Indomethacin Extended-Release Capsules USP 75 mg of Epic Pharma, USA, under fed condition in normal, healthy, adult, male and female human subjects in a randomized crossover study. The study was conducted with 32 healthy adult subjects. In each study period, a single 75 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 10 days including washout period of at least 7 days between administrations of study drug in each study period.

Conditions

• Fed

Interventions

Type	Name	Description
DRUG	Indomethacin Extended-Release Capsules USP 75 mg	75 mg tablet once a day
DRUG	Indomethacin Extended Release Capsules USP 75 mg	75 mg tablet once a day

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-11-06
• Last updated: 2012-11-06

Locations

1 site across 1 country: India