NCT03905564View on ClinicalTrials.gov

A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions

PHASE1WithdrawnINTERVENTIONAL

Timeline

Start Date

June 30, 2019

Primary Completion Date

June 30, 2020

Study Completion Date

June 30, 2020

Conditions

Bioavailability

Interventions

DRUG

doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg combination

Delayed-release tablet containing a fixed-dose combination of doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg (product of Tecnandina, S.A. TENSA).

DRUG

Diclegis (Registered Trademark)

Delayed-release tablet containing a fixed-dose combination of doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg (product of Duchesnay Inc.).