Clinical Trial: Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Roxane Laboratories

Current Primary Outcome: Bioequivalence [ Time Frame: Baseline, Two period, Twenty-one day washout ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Roxane Laboratories

Dates:
Date Received: January 15, 2008
Date Started: April 2004
Date Completion:
Last Updated: January 31, 2008
Last Verified: January 2008