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

• ClinicalTrials.gov Identifier: NCT01630902
• Recruitment Status: Completed
• First Posted: June 28, 2012
• Last Update Posted: June 28, 2012
• Sponsor: Torrent Pharmaceuticals Limited
• Information provided by (Responsible Party): Torrent Pharmaceuticals Limited

Study Description

Brief 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 21 days during fasting study.

Study Design:

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Torrent's Felodipine Extended-Release Tablets	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• 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

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes 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

Locations

India

Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.

Village Bhat, Gandhinagar, Gujarat, India

Sponsors and Collaborators

Torrent Pharmaceuticals Limited

More Information

• Responsible Party: Torrent Pharmaceuticals Limited
• ClinicalTrials.gov Identifier: NCT01630902
• Other Study ID Numbers: PK-09-183
• First Posted: June 28, 2012
• Last Update Posted: June 28, 2012
• Last Verified: June 2012

Additional relevant MeSH terms:

Malnutrition; Nutrition Disorders; Felodipine; Anti-Arrhythmia Agents; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents