NCT01744873

Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition

A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg of With Zebeta® 10 mg in Normal, Healthy, Adult, Human Subjects Under Fed Condition.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: IPCA Laboratories Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open Label, balanced, 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 human subjects.

Detailed description

Objective of this pivotal study was to assess the bioequivalence between Test Product: Bisoprolol Fumarate Tablet 10 mg of Ipca Laboratories Limited, India and the corresponding Reference Product: Zebeta® (Bisoprolol Fumarate) Tablets 10 mg of Duramed Pharmaceuticals Inc., USA under fed condition in normal, healthy, adult, human subjects in a randomized crossover study. The study was conducted with 24 healthy adult subjects. In each study period, a single 10 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 15 days including washout period of at least 10 days between administrations of study drug in each study period.

Conditions

• Fed

Interventions

Type	Name	Description
DRUG	Bisoprolol Fumarate Tablet 10 mg	10 mg tablet once a day
DRUG	Bisoprolol	10 mg tablet once a day

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-12-07
• Last updated: 2012-12-07

Locations

1 site across 1 country: India