Fed Clinical Trial
Official title:
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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