drugset / Trial / NCT03183297
Study to Evaluate the Pharmacokinetics and Pharmacodynamics of JMI-001
RandomizedCrossoverTriple-blindPrevention
Summary
This will be a double-blind, placebo-controlled study with a 4-way crossover design with subjects administered study drug (JMI-001), placebo, fexofenadine alone and naproxen alone on different study days, in conjunction with a quantity of alcohol estimated to be sufficient to produce a hangover the next day. The primary objective of the study is the evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of two different doses of JMI-001 administered in conjunction with alcohol to healthy adult subjects.
Timeline
- Start
- 2017-08
- Primary completion
- 2017-10
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fexofenadine | Unknown | 60 mg | — |
| Subject | Fexofenadine | Unknown | 120 mg | — |
| Subject | Naproxen | Small molecule | 220 mg | — |
| Subject | Naproxen | Small molecule | 440 mg | — |
Indications
No indication recorded.