Veisalgia Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics at Two Dose Levels of JMI-001 in Comparison With Fexofenadine and Naproxen Administered in Conjunction With Alcohol.
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.
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 and pharmacodynamics of two different doses of JMI-001 administered in conjunction with alcohol to healthy adult subjects. The secondary objective of this study is to compare the PK characteristics of fexofenadine administered as JMI-001 with administration of fexofenadine alone, and the PK characteristics of naproxen administered as JMI-001 with administration of naproxen alone. To compare overall hangover severity after administering JMI-001 with overall hangover severity after administration of fexofenadine alone or naproxen alone. To analyze possible quantitative differences in symptom profiles by treatment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02737397 -
Safety and Efficacy of a Combination Product for the Prevention of Veisalgia
|
Phase 2 |