Bioequivalence Clinical Trial
Official title:
Bioavailability of a Formulation of Estradiol Valerate and Dienogest 2 mg/2 mg Coated Tablets With Regards to the Marketed Reference Product
This study will investigate the bioavailability in fasting healthy, adult, human post-menopausal female subjects of 1 tablet formulation containing Estradiol Valerate and Dienogest 2 mg/ 2mg. The study will be performed at a single site with 10 subjects. Participants will take 1 tablet 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 7 days between each study period.
The primary objective of the study is to investigate the relative bioavailability of Estradiol Valerate and Dienogest 2mg/ 2mg of 1 tablet formulations with Estradiol Valerate and Dienogest 2mg/ 2mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption: - Test Product: Product manufactured by Laboratorios Andromaco S.A. - Reference Product: Climodien [Trademark], product Bayer plc. 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 Estradiol and Dienogest will be determined. Participants will be confined in the study site for approximately 42 hours during the entire study (for 10 hours pre-dosing and for 32 hours post dosing in both periods) during which pharmacokinetic (PK) blood samples will be obtained. 26 blood samples will be taken up to 72 hours after the administration in each period. The washout period between the two study periods will be at least 7 days. The samples from each participant will be analyzed with validated LC-MS/MS method for estimation of Estradiol and Dienogest in plasma. The safety objective is to evaluate the tolerability of both formulations in subjects by collecting adverse events. ;
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