Bioequivalence Clinical Trial
Official title:
Bioavailability of a Formulation of Levonorgestrel and Ethinyl Estradiol 15.0 mg/0.03 mg Coated Tablets With Regards to the Marketed Reference Product
This Pivotal study will investigate the bioavailability in women of 2 tablet formulations containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The Pivotal study will be performed at a single site with 30 subjects. Participants will take 2 tablets 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 14 days between each study period.
The primary objective of the study is to investigate the relative bioavailability of Levonorgestrel and Ethinyl estradiol of 2 tablet formulations with Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption: - Test Product: Product manufactured by Laboratorios Andrómaco S.A. - Reference Product: Microgynon [Trademark], product of Bayer AG, Germany. The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters área under the plasma concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72 hours (AUC0-72), and maximum plasma concentration (Cmax) for total Levonorgestrel and Ethinyl estradiol will be determined. Participants will be confined in the study site for approximately 36 hours during each study period (for 12 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. 16 blood samples will be taken up to 24 hours after the administration in each period. Participants will return to the site to provide additional blood samples at 48 h, and 72 h postdose. The washout period between the two study periods will be at least 14 days. The samples from each participant will be analyzed with 2 methods of highperformance liquid chromatography-tandem mass spectrometry bioanalytical assays to quantify total Levonorgestrel and Ethinyl estradiol in plasma. The safety objective is to evaluate the tolerability of both formulations in women by collecting adverse events. ;
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