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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Naproxen (Proxen S); Drug: PN400; Drug: Naproxen (Naprosyn E)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761501

D1120C00001

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: 38 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

38 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: PN400

2

Active Comparator group

Treatment:

Drug: Naproxen (Proxen S)

3

Active Comparator group

Treatment:

Drug: Naproxen (Naprosyn E)