NCT00602017

Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions

A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 10 mg Amlodipine Besylate Tablets Under Fasting Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Roxane Laboratories · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Conditions

• Hypertension
• Chronic Stable Angina
• Vasospastic Angina

Interventions

Type	Name	Description
DRUG	Amlodipine

Timeline

• Start date: 2004-04-01
• Primary completion: 2004-05-01
• Completion: 2004-05-01
• First posted: 2008-01-28
• Last updated: 2018-01-23

Locations

1 site across 1 country: United States