Clinical Trial: Bioequivalency Study of Amlodipine Tablets Under Fed 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 Fed 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 fed 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