Healthy
Conditions
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
Interventions
Sponsors
Torrent Pharmaceuticals Limited
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
India
Outcome results
None listed