Completed

Morpheus PKA Bioavailability Study of Naproxen Sodium and Diphenhydramine Hydrochloride Under Fasting Conditions and Naproxen Sodium and Diphenhydramine Hydrochloride Combination Under Fasting and Fed Conditions

What is being tested

BAY98-7111

+ Naproxen Sodium (Aleve, BAYH6689)

+ Diphenhydramine HCl

Drug

Who is being recruted

From 18 to 55 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Phase 1

Interventional

Study Start: January 2012

See protocol details

Summary

Principal SponsorBayer

Last updated: August 21, 2014

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01666678

Principal SponsorBayer

Last updated: August 21, 2014

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight > 50 kg (110 lbs)

Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy

Health, ambulatory male and female subjects between 18 to 55 years of age inclusive

Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator or Sponsor

10 exclusion criteria prevent from participating

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases or malignancies

Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) 7 days prior to dosing or during the Dosing Periods, other than trial treatment

Have taken any vitamin or herbal supplement within 7 days prior to dosing or refuse to refrain from use during the trial

History of gastrointestinal bleeding or perforation, related to previous NSAID therapy or active or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Group III

Active Comparator

Group IV

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hackensack, United StatesOpen in Google Maps

CompletedOne Study Center