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Bioequivalence of Doxylamine + Pyridoxine vs Diclectin in Healthy Volunteers
NCT06342778Phase 1Completed
- Sponsor
- Valenta Pharm
- Start
- Feb 2024
- Primary completion
- May 2024
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of doxylamine succinate + pyridoxine in nausea and vomiting of pregnancy (NVP) (2 arms), sponsored by Valenta Pharm. Primary endpoints: Maximum Plasma Concentration (Cmax), Area Under the Curve to Last Timepoint (AUC0-t) and 4 more. Started Feb 2024; status: completed.
02
Drugs
doxylamine succinate + pyridoxine
03
Conditions
nausea and vomiting of pregnancy (NVP)
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