NCT07487909

A Study of SJP-001 in Comparison With Fexofenadine and Naproxen Administered With Alcohol

A Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics at Two Dose Levels of SJP-001 in Comparison With Fexofenadine and Naproxen Administered in Conjunction With Alcohol.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Sen-Jam Pharmaceutical · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be a double-blind, placebo-controlled study with a 4-way crossover design with subjects administered study drug (SJP-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 amount of alcohol may vary from subject to subject, however each subject will consume the same types and amounts of alcohol on each subsequent treatment day as consumed on the first.

Detailed description

At each of four treatment visits, each separated by a minimum 7-day washout (i.e., the treatment day followed by a minimum of 6 subsequent non-treatment days), subjects will be administered SJP-001, placebo, fexofenadine alone and naproxen alone. Subjects will be randomized equally to one of four treatment sequences, according to a schedule prepared prior to the start of the study. Treatments will be administered 15 minutes before the start of a maximum 3-hour interval during which subjects will drink their choice of a selection of alcoholic and non-alcohol beverages. The amount of alcohol consumed will be targeted to achieve a breath alcohol content (BrAC) of 0.08%, a level estimated to be sufficient to produce a hangover the following day.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Treatment A- Fexofenadine HCl 60mg	One oral capsule containing 60 mg fexofenadine HCl plus one matching placebo capsule
DRUG	Treatment B- Naproxen sodium 220mg	One oral capsule containing 220 mg naproxen sodium plus one matching placebo capsule
DRUG	Treatment C- SJP-001 280mg	SJP-001 (One oral capsule containing 60 mg fexofenadine HCl plus one oral capsule containing no more than 275 mg (preferably 220 mg) naproxen sodium)
DRUG	Treatment D- Placebo-1	Two oral placebo capsules matching the appearance of other study treatments
DRUG	Treatment E- Fexofenadine HCl 120mg	Two oral capsules containing 60 mg fexofenadine HCl (120 mg total) plus two matching placebo capsules
DRUG	Treatment F- Naproxen sodium 440mg	Two oral capsules containing 220 mg naproxen sodium (440mg maximum total) plus two matching placebo capsules
DRUG	Treatment G- SJP-001 560mg	JP-001 (Two oral capsules containing 60 mg fexofenadine HCl \[120 mg total\] plus two oral capsules containing 220 mg naproxen sodium (560 mg) maximum total\])
DRUG	Treatment H- Placebo 2	Four oral placebo capsules matching the appearance of other study treatments

Timeline

• Start date: 2025-09-30
• Primary completion: 2025-11-21
• Completion: 2025-11-21
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study