NCT00865891

A Relative Bioavailability Study of 60 mg Nifedipine Extended Release Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the relative bioavailability of Nifedipine ER tablets 60 mg by Abrica Pharmaceuticals LLLP with that of ADALAT® CC Extended Release Tablets 60 mg by Bayer Pharmaceuticals Corporation, Bayer HealthCare following a single oral dose (1 x 60 mg tablet) 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 60 mg Nifedipine Extended Release tablets 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	Nifedipine Extended Release tablets 60 mg, single dose	A: Experimental Subjects received Abrica Pharmaceuticals LLLP formulated products under fasting conditions
DRUG	ADALAT® CC Extended Release Tablets 60 mg	B: Active comparator Subjects received Bayer Pharmaceuticals Corporation, Bayer HealthCare formulated products under fasting conditions

Timeline

• Start date: 2005-07-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2009-03-19
• Last updated: 2010-08-17

Locations

1 site across 1 country: United States