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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00907400
First received: May 21, 2009
Last updated: December 8, 2010
Last verified: December 2010
History of Changes
  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 1

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:

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 June 13, 2013