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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT01630902
First received: June 26, 2012
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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 21 days during fasting study.

Study Design:

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


Condition Intervention Phase
Healthy
Drug: Torrent's Felodipine Extended-Release Tablets
Phase 1

Study Type: Interventional
Official Title: 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 Fed Condition

Resource links provided by NLM:


Further study details as provided by Torrent Pharmaceuticals Limited:

Primary Outcome Measures:
  • bioequivalence based on Composite of Pharmacokinetics [ Designated as safety issue: No ]
    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.


  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The volunteers were included in the study based on the following criteria:

  • Sex: male.
  • Age: 18 - 45 years.
  • Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
  • Healthy and willing to participate in the study.
  • Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
  • Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

  • Clinically relevant abnormalities in the results of the laboratory screening evaluation.
  • Clinically significant abnormal ECG or Chest X-ray.
  • Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.

Pulse rate less than 50/minute or more than 100/minute.

  • Oral temperature less than 95°P or more than 98.6°P.
  • Respiratory rate less than 12/minute or more than 20/minute
  • History of allergy to the test drug or any drug chemically similar to the drug under investigation.
  • History of alcohol or drug abuse
  • Positive breath alcohol test
  • Recent history of kidney or liver dysfunction.
  • History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
  • Volunteers suffering from any chronic illness such as arthritis, asthma etc.
  • History of heart failure.
  • HIV, HCV, HBsAg positive volunteers.
  • Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.
  • Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
  • Administration of any study drug in the period 0 to 3 months before entry to the study.
  • History of significant blood loss due to any reason, including blood donation in the past 3 months.
  • History of pre-existing bleeding disorder.
  • Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
  • Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630902

Locations
India
Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.
Village Bhat, Gandhinagar, Gujarat, India
Sponsors and Collaborators
Torrent Pharmaceuticals Limited
  More Information

No publications provided

Responsible Party: Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT01630902     History of Changes
Other Study ID Numbers: PK-09-183
Study First Received: June 26, 2012
Last Updated: June 27, 2012
Health Authority: India: Drugs Controller General of India
India: Indian Council of Medical Research

Additional relevant MeSH terms:
Felodipine
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on October 02, 2014