check_circleStudy Completed
Pharmacokinetics
Bayer Identifier:
14566
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Pharmacokinetics study comparing Naproxen Sodium Extended Release and Naprelan
Trial purpose
To compare the pharmacokinetic profile of the proposed extended- release tablet of naproxen sodium 660 mg relative to two tablets of Naprelan 500 mg following single dose administration for 36 hours under fasted conditions
Key Participants Requirements
Sex
BothAge
18 - 55 YearsTrial summary
Enrollment Goal
28Trial Dates
April 2009 - May 2009Phase
Phase 1Could I Receive a placebo
NoProducts
Aleve (Naproxen Sodium ER, BAY117031)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | PPD Development | Austin, 78744, United States |
Primary Outcome
- Pharmacokinetic profile of Naproxen Sodium ER 660 mg compared to Naprelandate_rangeTime Frame:36 hoursenhanced_encryptionyesSafety Issue:
Secondary Outcome
- To assess safety and tolerability of the extended release naproxen sodiumdate_rangeTime Frame:36 hoursenhanced_encryptionyesSafety Issue:
- To assess additional pharmacokinetic parametersdate_rangeTime Frame:36 hoursenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2