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

June 27, 2012 updated by: Torrent Pharmaceuticals Limited

An Open Label, Randomised, 2-period, 2-treatment, 2-sequence, Cross-over, Single-dose Bioequivalence Study of Felodipine Extended-Release Tablets USP 10 mg (Test, Torrent Pharmaceuticals Ltd., India) Versus Felodipine Extended-Release Tablets USP 10 mg (Reference, Mylan Pharmaceuticals Inc., USA) in Healthy Human Volunteers Under Fasting Condition

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Hyderabad
      • Miyapur, Hyderabad, India, 500 050
        • AXIS Clinicals Limited(formerly Trident Life Sciences Ltd.)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy males within the age range of 18 to 50 years.
  • A body mass index within 18-25 Kg/m2.
  • Given written informed consent to participate in the study.
  • Absence of diseases markers of HIV 1 & 2, Hepatitis B & C virus and RPR.
  • Absence of significant disease or clinically significant abnormal laboratory
  • values on laboratory evaluation, medical history and physical examination during the screening.
  • A normal 12-lead ECG.
  • A normal chest X-Ray.
  • Comprehension of the nature and purpose of the study and compliance with the requirements of the entire protocol.
  • No history or no evidence of hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.
  • No history of allergic rash.
  • No history of significant systemic diseases.
  • No history of psychiatric disorders or addiction to any recreational drug or drug dependence.
  • No donation of blood within 56 days prior to study check-in.
  • No participation in any clinical study within the past 56 days.
  • No receipt of any prescription drugs or OTC products, with in two weeks prior to study check-in.
  • No history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study check-in.
  • No family history of neurological disorders.
  • Not consumed alcohol and xanthine containing food and beverages, cigarettes and tobacco products, for at-list 48 hours, prior to study check-in.
  • Negative results for drugs of abuse in urine and alcohol breath analysis during check-in of each period.
  • Not consumed grape fruit juice within the 48 hours prior to study check-in.

Exclusion Criteria:

  • Blood pressure Systolic> 140 mm Hg and < 110 mm Hg Diastolic< 70 mm Hg > 90 mm Hg
  • History of seizures
  • History of alcohol consumption for more than 2 units/day.
  • High caffeine or tobacco consumption
  • History of difficulty with donating blood or difficulty in accessibility of veins.
  • Any unusual or abnormal diet, for whatever reason e.g. fasting due to religious reasons.
  • Used any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
bioequivalence based on Composite of Pharmacokinetics
bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Torrent Pharmaceuticals Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimate)

June 28, 2012

Study Record Updates

Last Update Posted (Estimate)

June 28, 2012

Last Update Submitted That Met QC Criteria

June 27, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 426-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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