NCT00865215

A Relative Bioavailability Study of Propranolol Hydrochloride 160 mg Tablets Under Fasting Conditions

A Relative Bioavailability Study of 160 mg Propranolol Hydrochloride Extended Release Capsules Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is TO compare the relative bioavailability of Propranolol Hydrochloride Extended Release Capsules 160 mg (Actavis) with that of INDERAL® LA 160 mg Capsules (Wyeth Pharmaceuticals) following a single oral dose (1 x 160 mg) in healthy adult volunteers under fasting conditions.

Detailed description

Study Type: Interventional Study Design: Randomized, single dose, two-way crossover study under fasting conditions Official Title: A Relative Bioavailability Study of 160 mg Propranolol Hydrochloride Extended Release Capsules Under Fasting Conditions Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Propranolol Hydrochloride Extended Release Capsules 160 mg	A: Experimental Subjects received Actavis formulated products under fasting conditions
DRUG	INDERAL® LA 160 mg Capsules, single dose	B: Active comparator Subjects received Wyeth Pharmaceuticals formulated products under fasting conditions

Timeline

• Start date: 2005-04-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2009-03-19
• Last updated: 2010-08-17

Locations

1 site across 1 country: United States