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

NCT01630655 | Completed Phase 1

• 1 other identifier: 426-09
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 17 days during fasting study. Study Design: Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

Conditions

Healthy

Outcome Measures

Primary Outcomes (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.

Interventions

Torrent's Felodipine Extended-Release Tablets DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

Study Sites (1)

AXIS Clinicals Limited(formerly Trident Life Sciences Ltd.)

Miyāpur, Hyderabad, 500 050, India

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

IN (1)