NCT00647608

Food Study of Propranolol Hydrochloride Extended-Release Capsules 160 mg and Inderal® LA Capsules 160 mg

Single-Dose Fed Bioequivalence Study of Propranolol Hydrochloride Extended-Release Capsules (160 mg; Mylan) and Inderal® LA Capsules (160 mg; Wyeth) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's propranolol hydrochloride extended-release 160 mg capsules to Wyeth's Inderal® LA 160 mg capsules following a single, oral 160 mg (1 x 160 mg) dose administered under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Propranolol Hydrochloride Extended-Release Capsules 160 mg	160mg, single dose fed
DRUG	Inderal® LA Capsules 160 mg	160mg, single dose fed

Timeline

• Start date: 2005-09-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States