Fed Clinical Trial
Official title:
An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg of Ipca Laboratories Limited, India and 'Toprol-XL®' (Metoprolol Succinate) Extended Release Tablets 200 mg of Astrazeneca LP, USA In Healthy Adult Human Subjects Under Fed Conditions
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in healthy adult human subjects.
Objective of this pivotal study was to assess the bioequivalence between Test Product:
Metoprolol Succinate 200 mg Ipca Laboratories Limited, India and the corresponding Reference
Product: TOPROL-XL® (Metoprolol Succinate) extended release Tablets 200 mg of Astrazenica
LP, USA under fed condition in healthy adult human subjects in a randomized crossover study.
The study was conducted with 48 healthy adult subjects. In each study period, a single 200
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 11 days including washout period of at
least 7 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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