NCT00932880

Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets (Torrent Pharmaceuticals Limited) Compared to a 10 mg Dose of Norvasc® (Pfizer) in 18 Fed, Healthy Adult Subjects

An Open-Label, Randomized, Two-Way Crossover, Single Dose Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets [Torrent Pharmaceuticals Limited,India] Compared to a 10 mg Dose of Norvasc®, [Pfizer, USA] in 18 Fed, Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: —

Summary

* Objective: * The objective of this study was to compare the rate and extent of absorption of the test formulation, amlodipine besylate 10 mg tablets (Torrent Pharmaceuticals Ltd.), with that of the marketed reference product, Norvasc® 10 mg tablets (Pfizer, Inc.), when administered under fed conditions. * Study Design: * This was an open-label, randomized, two-way crossover study in which 18 healthy subjects were scheduled to receive a single dose of each of two treatments in two assigned dosing periods. Each dose administration was separated by a minimum 14-day washout period.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Amlodipine Besylate	10 mg tablets (Torrent Pharmaceuticals, India)
DRUG	Norvasc	10 mg dose (Pfizer, USA)

Timeline

• First posted: 2009-07-03
• Last updated: 2009-07-16

Locations

1 site across 1 country: United States