drugset / Trial / NCT03905564
A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions
RandomizedCrossoverOpen-labelTreatment
Summary
The purpose of the study is to investigate any difference in the extent and rate of absorption of doxylamine between the test (investigational medicinal product \[IMP\]) and reference products that could impact the bioavailability of the medication when administered under fasting conditions.
Timeline
- Start
- 2019-06
- Primary completion
- 2020-06
- Completion
- 2020-06
Outcome
Outcome not reported
Stopped (Business): “Sponsor decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Diclegis (Registered Trademark) | Unknown | 20 mg | Oral |
| Subject | doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg combination | Unknown | 20 mg | Oral |
Indications
No indication recorded.