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

This study has been completed.

First Received on May 21, 2009. Last Updated on December 8, 2010 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00907400

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: PN400 Drug: Naproxen	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	Phase I, Open-label, Randomized, 2-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Naprosyn E Under Fasting and Fed Conditions in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Pharmacokinetics [ Time Frame: pre-dose and multiple times post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	48
Study Start Date:	May 2009
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 PN400	Drug: PN400 oral tablet Other Name: VIMOVO™
Active Comparator: 2 Naprosyn E	Drug: Naproxen oral tablet Other Name: Naprosyn E

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907400

Locations

Sweden
Research Site
Lulea, Sweden
Research Site
Uppsala, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Mark Sostek, MD	AstraZeneca
Principal Investigator:	Aslak , Rautio, MD	Quintiles Hermelinen
Principal Investigator:	Elisabeth Eden, MD	Quintiles AB

More Information

No publications provided

Responsible Party:	Mark Sostek, MD, Medical Science Director, Development Projects, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00907400 History of Changes
Other Study ID Numbers:	D1120C00024, EudraCT No 2009-011738-87
Study First Received:	May 21, 2009
Last Updated:	December 8, 2010
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Phase 1
Healthy Volunteer
Healthy Volunteer Study

Additional relevant MeSH terms:

Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012