check_circleStudy Completed
Pain
Bayer Identifier:
13965
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Naproxen Sodium ER Pharmacokinetic Study
Trial purpose
To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.
Key Participants Requirements
Sex
BothAge
18 - 55 YearsTrial summary
Enrollment Goal
32Trial Dates
November 2008 - November 2008Phase
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 (PK) Profile of an extended release tablet of Naproxen Sodium under fed conditionsdate_rangeTime Frame:4 weeksenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Assess the safety and tolerability of an extended release tablet of Naproxen Sodiumdate_rangeTime Frame:4 weeksenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2