NCT01884857

Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 50 mg

An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 50 mg of Ipca Laboratories Limited, India and 'Toprol-XL®' (Metoprolol Succinate) Extended Release Tablets 50 mg of Astrazeneca LP, USA In Healthy Adult Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: IPCA Laboratories Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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 fasting condition in healthy adult human subjects.

Detailed description

Objective of this pivotal study was to assess the bioequivalence between Test Product: Metoprolol Succinate 50 mg Ipca Laboratories Limited, India and the corresponding Reference Product: TOPROL-XL® (Metoprolol Succinate) extended release Tablets 50 mg of Astrazenica LP, USA under fasting 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 50 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.

Conditions

• Fasting

Interventions

Type	Name	Description
DRUG	Metoprolol Succinate ER Tablets 50 mg	1\* 50 mg tablet once a day
DRUG	'TOPROL-XL®' ER Tablets 50 mg	1 \* 50 mg tablet per day

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-06-24
• Last updated: 2013-06-24

Locations

1 site across 1 country: India