Healthy Volunteer
Conditions
Keywords
Phase I, Healthy Volunteer
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 comparable to that of currently marketed naproxen tablets.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | pre-dose and multiple times post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Safety | Throughout study |
Countries
Sweden
Outcome results
None listed