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

Phase 1/2 Completed 47 enrolled Sen-Jam Pharmaceutical Cliantha Research · collab

RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start: 2025-09-30
Primary completion: 2025-11-21
Completion: 2025-11-21

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fexofenadine	Unknown	60 mg	Oral
Subject	Fexofenadine	Unknown	120 mg	Oral
Subject	Naproxen	Small molecule	220 mg	Oral
Subject	Naproxen	Small molecule	440 mg	Oral
Subject	SJP-001	Unknown	280 mg	Oral
Subject	SJP-001	Unknown	560 mg	Oral

Indications

No indication recorded.