Overview

A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects

Status:
Completed

Trial end date:
2018-03-29

Target enrollment:

Participant gender:

Summary

To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration under fasted condition in healthy adults subjects. To assess the safety and tolerability of the investigational products in terms of advent events (AEs) and clinical parameters.

Phase:

Phase 1

Details

Lead Sponsor:

Bayer

Treatments:

Diphenhydramine
Naproxen
Promethazine