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

NCT03396250 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-03-20

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2018-03-26
Completion
2018-03-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03396250 on ClinicalTrials.gov