Bioequivalence Clinical Trial
Official title:
Bioavailability of a Formulation of Oseltamivir Phosphate 75 mg Capsules With Regards to the Reference Product
This study will investigate the bioavailability in fasting male and/or non-pregnant and non- breast feeding female subjects of 1 capsule formulation containing Oseltamivir Phosphate 75 mg. The study will be performed at a single site with 36 subjects. Participants will take 1 capsule of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 2 days between each study period.
The primary objective of the study is to investigate the relative bioavailability of Oseltamivir Phosphate 75 mg of 1 capsule formulations with Oseltamivir Phosphate 75 mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption: - Test Product: Product manufactured by Laboratorios Silesia S.A. - Reference Product: Tamiflu [Trademark], product of Roche Pharma AG, Switzerland. The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters area under the plasma concentration-time curve from time zero to time t (AUC0 0-t) and from time zero to infinite (AUC0 0-∞), and maximum plasma concentration (Cmax) for total Oseltamivir Phosphate will be determined. Participants will be confined in the study site for approximately 68 hours during the entire study (for 10 hours pre-dosing and for 10 hours post dosing in period II) during which pharmacokinetic (PK) blood samples will be obtained. 20 blood samples will be taken up to 10 hours after the administration in each period. The washout period between the two study periods will be at least 2 days. The samples from each participant will be analyzed with validated LC-MS/MS method for estimation of Oseltamivir in plasma. The safety objective is to evaluate the tolerability of both formulations in subjects by collecting adverse events. ;
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