Bioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fasting Condition
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy males within the age range of 18 to 50 years.
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A body mass index within 18-25 Kg/m2.
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Given written informed consent to participate in the study.
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Absence of diseases markers of HIV 1 & 2, Hepatitis B & C virus and RPR.
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Absence of significant disease or clinically significant abnormal laboratory
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values on laboratory evaluation, medical history and physical examination during the screening.
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A normal 12-lead ECG.
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A normal chest X-Ray.
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Comprehension of the nature and purpose of the study and compliance with the requirements of the entire protocol.
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No history or no evidence of hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.
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No history of allergic rash.
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No history of significant systemic diseases.
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No history of psychiatric disorders or addiction to any recreational drug or drug dependence.
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No donation of blood within 56 days prior to study check-in.
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No participation in any clinical study within the past 56 days.
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No receipt of any prescription drugs or OTC products, with in two weeks prior to study check-in.
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No history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study check-in.
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No family history of neurological disorders.
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Not consumed alcohol and xanthine containing food and beverages, cigarettes and tobacco products, for at-list 48 hours, prior to study check-in.
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Negative results for drugs of abuse in urine and alcohol breath analysis during check-in of each period.
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Not consumed grape fruit juice within the 48 hours prior to study check-in.
Exclusion Criteria:
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Blood pressure Systolic> 140 mm Hg and < 110 mm Hg Diastolic< 70 mm Hg > 90 mm Hg
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History of seizures
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History of alcohol consumption for more than 2 units/day.
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High caffeine or tobacco consumption
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History of difficulty with donating blood or difficulty in accessibility of veins.
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Any unusual or abnormal diet, for whatever reason e.g. fasting due to religious reasons.
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Used any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AXIS Clinicals Limited(formerly Trident Life Sciences Ltd.) | Miyapur | Hyderabad | India | 500 050 |
Sponsors and Collaborators
- Torrent Pharmaceuticals Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 426-09