check_circleStudy Completed
Bioavailability
Bayer Identifier:
13080
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Fast & Fed Pharmacokinetic (PK) Study
Trial purpose
The purpose of this study is to provide information on how well an extended release formulation (a medication that is released and absorbed over a longer period of time than a regular release formulation of the medication) of naproxen sodium is absorbed into the bloodstream after eating a high calorie breakfast and also after fasting (not eating for 14 hours).
Key Participants Requirements
Sex
BothAge
18 - 55 YearsTrial summary
Enrollment Goal
32Trial Dates
January 2008 - March 2008Phase
Phase 1Could I Receive a placebo
NoProducts
Aleve (Naproxen Sodium ER, BAY117031)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Arkansas Research Medical Testing, LLC | Little Rock, 72202, United States |
Primary Outcome
- PK parametersdate_rangeTime Frame:Over 48 hoursenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Assess the tolerability of the investigational product.date_rangeTime Frame:Over 48 hoursenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2