NCT01630655CompletedPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Locations
- 2
- Primary Endpoint
- bioequivalence based on Composite of Pharmacokinetics
Study Overview
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
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy males within the age range of 18 to 50 years.
- •A body mass index within 18-25 Kg/m
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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