Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fasting Condition
Completed
IPCA Laboratories Ltd.
Phase 1
2012-08-01
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 fasting condition in
normal, healthy, adult human subjects.
Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition
Completed
IPCA Laboratories Ltd.
Phase 1
2012-08-01
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.
The aim of the study is to evaluate whether combined therapy with beta-blocker, amiodarone
and statine is better than beta-blocker alone for the prevention of atrial fibrillation after
coronary by-pass surgery.
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