drugset / Trial / NCT03183297

Study to Evaluate the Pharmacokinetics and Pharmacodynamics of JMI-001

NCT03183297

Phase 1 Unknown 48 enrolled Sen-Jam Pharmaceutical
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

EvaluationDrugModalityDoseRoute
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.