Bioequivalence Clinical Trial
Official title:
Bioavailability of a Formulation of Desogestrel 0.075 mg Coated Tablets With Regards to the Marketed Reference Product
This Pivotal study investigated the bioavailability in women of 2 tablet formulations containing Desogestrel 0.075 mg. The Pivotal study was performed at a single site with 30 subjects. Participants took 2 tablets of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There was a washout of 14 days between each study period.
The primary objective of the study is to investigate the relative bioavailability of
Desogestrel of 2 tablet formulations with Desogestrel 0.075 mg 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: Cerazette [Trademark], product of Merck Sharp and Dohme Ltda.,
Brasil.
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 metabolite etonogestrel was
determined.
Participants were 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 were obtained. 16 blood samples were taken up to 24 hours after the
administration in each period. Participants returned to the site to provide additional blood
samples at 48 h, and 72 h postdose.
The washout period between the two study periods was 14 days. The samples from each
participant were analyzed with 2 methods of highperformance liquid chromatography-tandem mass
spectrometry bioanalytical assays to quantify total Dienogest and Ethinyl estradiol in
plasma.
The safety objective was to evaluate the tolerability of both formulations in women by
collecting adverse events.
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