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

PHASE1WithdrawnINTERVENTIONAL
0
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.).

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Grünenthal, S.A.

INDUSTRY

lead

Grünenthal GmbH

INDUSTRY