NCT01673997

Bioequivalence Study of Metoprolol Succinate ER Tablets, 200 mg Under Fasting Conditions

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Metoprolol Succinate Extended-Release Tablets 200mg of Dr. Reddy's Laboratories Limited, India Comparing With That of TOPROL-XL® (Containing Metoprolol Succinate) Extended-Release Tablets 200mg of AstraZeneca LP Wilmington, DE in Healthy, Adult, Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: —
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol Succinate Extended-Release Tablets 200 mg under fasting conditions

Detailed description

An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study of Metoprolol Succinate Extended-Release tablets 200mg of Dr. Reddy's Laboratories Limited,under fasting conditions

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Metoprolol Succinate	Metoprolol Succinate ER Tablets 200 mg

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2012-08-28
• Last updated: 2012-09-25

Locations

1 site across 1 country: India