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Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination

NCT01666678 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-08-21

No results posted yet for this study

Summary

The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.

Conditions

  • Therapeutic Equivalence

Interventions

DRUG

BAY98-7111

2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fasting conditions

DRUG

Naproxen Sodium (Aleve, BAYH6689)

2 x Naproxen Sodium 220 mg under fasting conditions

DRUG

Diphenhydramine HCl

2 x Diphenhydramine HCl 25 mg under fasting conditions

DRUG

BAY98-7111

2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fed conditions

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01666678 on ClinicalTrials.gov