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Bioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fasting Condition

NCT01630655 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2012-06-28

No results posted yet for this study

Summary

Objective:

Primary objective of the present study was to compare the single dose bioavailability of Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods were separated by a washout period of 17 days during fasting study.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

Conditions

  • Healthy

Interventions

DRUG

Torrent's Felodipine Extended-Release Tablets

Sponsors & Collaborators

  • Torrent Pharmaceuticals Limited

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • India

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 NCT01630655 on ClinicalTrials.gov