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Single Site, Open-label, Randomized, Two Treatments, Two Periods, Two Sequences, Crossover Trial to Evaluate the Bioequivalence of Two Delayed-release Oral Formulations of a Fixed Combination of Doxylamine Succinate 10 mg/Pyridoxine Hydrochloride 10 mg (Test Product: Product of Tecnandina, S.A. TENSA; Reference Product: Diclegis (Registered Trademark) Product of Duchesnay Inc.) After a Single Administration of Two Tablets to Healthy Women Under Fasting Conditions
Conditions
Interventions
doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg combination
Diclegis (Registered Trademark)
Start Date
June 1, 2019
Primary Completion Date
June 1, 2020
Completion Date
June 1, 2020
Last Updated
July 11, 2019
NCT07063173
NCT07345130
NCT07046975
NCT06882681
NCT06641245
NCT06177483
Lead Sponsor
Grünenthal GmbH
Collaborators
Data Source & Attribution
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