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Clinical trial

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

NCT03749733 is registered in ClinicalTrials.gov with Grünenthal GmbH as lead sponsor.

NCT NCT03749733
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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
Grünenthal GmbH
Phase
Phase 1
Overall status
Withdrawn
Start date
October 31, 2019
Completion date
December 31, 2019
Enrollment
0 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

bioequivalence