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

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

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