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Bioequivalence of Doxylamine + Pyridoxine vs Diclectin in Healthy Volunteers
NCT05498233Phase 1Completed
- Sponsor
- Valenta Pharm
- Start
- Aug 2022
- Primary completion
- Sep 2022
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of doxylamine succinate + pyridoxine in nausea and vomiting of pregnancy (NVP), sponsored by Valenta Pharm. Primary endpoints: Maximum Plasma Concentration (Cmax) for Doxylamine, Maximum Plasma Concentration (Cmax) for Pyridoxal-5-phosphate and 4 more. Started Aug 2022; status: completed.
02
Drugs
doxylamine succinate + pyridoxine
03
Conditions
nausea and vomiting of pregnancy (NVP)
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