check_circleStudy Completed
Healthy
Bayer Identifier:
13106
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Single/Multiple Dose Bioavailability Trial
Trial purpose
To determine the pharmacokinetic profile of an extended release tablet of naproxen sodium 660 mg relative to the established commercial Aleve 220 mg tablet following single dose administration and at steady-state following multiple dose administration for 4 days.
Key Participants Requirements
Sex
BothAge
18 - 55 YearsTrial summary
Enrollment Goal
32Trial Dates
February 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
- Pharmacokinetics parametersdate_rangeTime Frame:Over 48 Hoursenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Assess the safety and tolerability of the investigational productdate_rangeTime Frame:Over 48 Hoursenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2