Bioequivalence Clinical Trial
Official title:
Single Site, Open-label, Randomized, Two Treatments, Two Periods, Two Sequences, Crossover Single-dose Trial to Investigate the Bioequivalence of Two Oral Formulations of a Fixed-dose Combination Tablet Containing 1.5 mg Estradiol and 2.5 mg Nomegestrol Acetate (Product of Laboratorios Andrómaco S.A. [Test Product] Versus Stezza, Product of Merck Sharp & Dohme Farmacêutica Ltda. [Reference Product]) in Postmenopausal Women Under Fasting Conditions
This study will investigate the bioavailability in fasting post-menopausal women of 2
film-coated tablet formulations containing 1.5 milligrams (mg) of estradiol and 2.5 mg of
nomegestrol acetate.
The study will be performed at a single site. Participants will take a single oral dose 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 21 days between each
study period.
The primary objective of the study is to investigate the relative bioavailability of
estradiol and nomegestrol of 2 film-coated tablet formulations with estradiol 1.5 mg and
nomegestrol acetate 2.5 mg and to demonstrate bioequivalence of both formulations in terms of
rate and extent of absorption:
1. Test Product: new product manufactured by Laboratorios Andrómaco S.A.
2. Reference Product: Stezza [Trademark], product of Merck Sharp & Dohme Farmacêutica Ltda.
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 estradiol/estrone and
nomegestrol 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. Three blood samples will be taken before the film-coated
tablet is administered (at pre-dose: -1.0, -0.5, and 0 h) and 16 samples up to 24 hours after
the administration in each period. Participants will return to the site to provide additional
blood samples at 36 h, 48 h, and 72 h post-dose.
The washout period between the two study periods will be at least 21 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
estradiol/estrone and nomegestrol in plasma with citrate phosphate dextrose anticoagulant.
The blood samples taken at pre-dose will be taken to establish the baseline concentrations of
total estrone and estradiol. The baseline-corrected and uncorrected AUCs and Cmax will be
calculated.
The safety objective is to evaluate the tolerability of both formulations in post-menopausal
women by collecting adverse events.
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