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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 22 Fasted, Healthy Adult Subjects

NCT00932763 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2009-07-17

No results posted yet for this study

Summary

* Objective:

* The objective of this study was to assess the relative bioavailability of two formulations of immediate release amlodipine 10 mg under fasted conditions, in healthy subjects.
* Study Design:

* This was an open-label, single-dose, 2-treatment, 2-period, randomized, crossover study.Twenty-two healthy subjects were enrolled. Subjects who successfully completed the screening process checked into the research center the night before first dose. Subjects who continued to meet inclusion/exclusion criteria the morning of dose were assigned a subject number, based on the order in which they successfully completed the screening process and procedures as outlined in the study protocol. Subjects were randomly assigned to a treatment sequence and received two separate single-dose administrations of study medication, one treatment per period,according to the randomization schedule. Dosing days were separated by a washout period of at least 14 days. Subjects received each of the treatments listed below during the two treatment periods following an overnight fast of at least 10 hours: amlodipine by Torrent Pharmaceuticals Ltd. and Norvasc by Pfizer, Inc.

Conditions

  • Healthy

Interventions

DRUG

Amlodipine besylate

10 mg tablets (Torrent Pharmaceuticals, India)

DRUG

Norvasc

10 mg dose (Pfizer, USA)

Sponsors & Collaborators

  • Torrent Pharmaceuticals Limited

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00932763 on ClinicalTrials.gov