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Clinical trial

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

NCT03905564 is registered in ClinicalTrials.gov with Grünenthal GmbH as lead sponsor.

NCT NCT03905564
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Grünenthal GmbH
Phase
Phase 1
Overall status
Withdrawn
Start date
June 30, 2019
Completion date
June 30, 2020
Enrollment
0 (actual)
Sites
Not reported

Conditions

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

bioavailability