drugset / Trial / NCT03312777
Omnitram Pharmacokinetic and Analgesic Study Following CY2D6 Inhibition With Paroxetine In Healthy Volunteers
Phase 1
Completed
60 enrolled
Syntrix Biosystems, Inc.
DF/Net Rearch · collabITT Research Institute · collabPRA Health Sciences · collab
RandomizedCrossoverQuadruple-blindTreatment
Summary
This study evaluates the analgesic effect of Omnitram and tramadol during concurrent administration of paroxetine. Paroxetine administration is expected to diminish the analgesic effect of tramadol, but not Omnitram. Each participant will receive paroxetine before and during treatment with Omnitram, tramadol, and placebo.
Timeline
- Start
- 2017-10-31
- Primary completion
- 2017-12-15
- Completion
- 2017-12-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Desmetramadol | Small molecule | 20 mg | Oral |
| Comparator | Tramadol | Other / unclassified | 50 mg | Oral |
Indications
No indication recorded.