NCT00870142

A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Under Fasting Conditions

Comparative, Randomized, Single Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®)10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fasting conditions.

Detailed description

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design. Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®) 10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers 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	AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose	A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fasting conditions
DRUG	Norvasc® 10 mg Tablets	B: Active comparator Subjects received Pfizer Labs Division of Pfizer Inc. formulated products under fasting conditions

Timeline

• Start date: 2005-04-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2009-03-27
• Last updated: 2010-08-16

Locations

1 site across 1 country: Canada