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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT01630655
• Lead Sponsor: Torrent Pharmaceuticals Limited

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-06
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-27
• Last Update Submitted: 2012-06-27
• Study First Posted: 2012-06-28
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

AXIS Clinicals Limited(formerly Trident Life Sciences Ltd.); 🇮🇳 Miyapur, Hyderabad, India