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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

Healthy Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00932880
Study type Interventional
Source Torrent Pharmaceuticals Limited
Contact
Status Completed
Phase Phase 1
View Details
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