Status:
COMPLETED
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comp...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg
- Clinically normal physical exams and laboratory measurements
Exclusion
- Subject has received another investigational drug within 4 weeks preceding this study or planning to participate in another study at any time during the period of this study
- Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial
- Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
- Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00761501
Start Date
September 1 2008
End Date
December 1 2008
Last Update
December 9 2010
Active Locations (2)
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1
Research Site
Luleå, Sweden
2
Research Site
Uppsala, Sweden