Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: PN400

Drug: Naproxen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00907400

EudraCT No 2009-011738-87

D1120C00024

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit
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