This Pilot study will investigate the bioavailability in fasting women of 2 tablet formulations containing Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg. The Pilot study will be performed at a single site with 10 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 Dienogest and Ethinyl estradiol of 2 tablet formulations with Dienogest 2.0 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: Valette \[Trademark\], product of Jenapharm, Germany. 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-t) and from time zero to 72 hours (AUC0-72), and maximum plasma concentration (Cmax) for total Dienogest 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 post-dose. 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 high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays to quantify total Dienogest and Ethinyl estradiol in plasma. The safety objective is to evaluate the tolerability of both formulations in women by collecting adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
Coated Tablets
Coated Tablets
Innolab
Santiago, Chile
Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72) ]
21 samples up to 72 hours will be taken after the administration in each period.
Time frame: From tablet intake and up to 72 hours after tablet intake
Total Dienogest: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72)
21 samples up to 72 hours will be taken after the administration in each period.
Time frame: From tablet intake and up to 72 hours after tablet intake
Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to time t (AUC0-t)
21 samples up to 72 hours will be taken after the administration in each period.
Time frame: From tablet intake and up to 72 hours after tablet intake
Total Dienogest: area under the plasma concentration-time curve from 0 to time t (AUC0-t)
21 samples up to 72 hours will be taken after the administration in each period.
Time frame: From tablet intake and up to 72 hours after tablet intake
Total Ethinyl estradiol: Maximum plasma concentration (Cmax)
21 samples up to 72 hours will be taken after the administration in each period.
Time frame: From tablet intake and up to 72 hours after tablet intake
Total dienogest: Maximum plasma concentration (Cmax)
21 samples up to 72 hours will be taken after the administration in each period.
Time frame: From tablet intake and up to 72 hours after tablet intake
Total dienogest: Time to achieve maximum plasma concentration (tmax)
21 samples up to 72 hours will be taken after the administration in each period.
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Time frame: From tablet intake and up to 72 hours after tablet intake
Total Ethinyl estradiol: Time to achieve maximum plasma concentration (tmax)
21 samples up to 72 hours will be taken after the administration in each period.
Time frame: From tablet intake and up to 72 hours after tablet intake