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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
48
JMI-001, a combination product of naproxen and fexofenadine
Naproxen sodium 220mg
Fexofenadine 60mg
Maximum Plasma Concentration (Cmax)
Maximum Plasma Concentration of each drug measured in ng/mL
Time frame: 24 hours
Time to Maximum Plasma Concentration (Tmax)
Time to achieve the (Cmax) for each drug measured in hours
Time frame: 24 hours
Area Under the Curve (AUC)
Area Under the Curve for each drug measured in h\*ng/mL
Time frame: 24 hours
Elimination half-life
Elimination half-life measured in hours
Time frame: 24 hours
Hangover Severity Score
Single item Hangover Score subjectively measured by the subject from 0=no symptoms to 10=worst symptoms
Time frame: 24 hours
Multiple Symptom Hangover Severity Score
A composite score derived from a spectrum of hangover symptoms (23-items) with each symptom subjectively measured by the subject from 0=no symptom to 10=worst symptom
Time frame: 24 hours
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