NCT03396250

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

An Open Label Crossover Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Naproxen sodium and diphenhydramine hydrochloride soft capsules	Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)
DRUG	Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)	Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)

Timeline

• Start date: 2018-02-12
• Primary completion: 2018-03-26
• Completion: 2018-03-29
• First posted: 2018-01-10
• Last updated: 2019-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study