Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E
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 comparable to that of currently marketed naproxen tablets.
Inclusion Criteria:

 -  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 Criteria:

 -  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