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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:
ClinicalTrials.gov Identifier:
NCT00907400
First Posted: May 22, 2009
Last Update Posted: December 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
Intervention Model: Crossover Assignment
Masking: None (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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: pre-dose and multiple times post-dose ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Throughout study ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 21, 2009
First Posted: May 22, 2009
Last Update Posted: December 10, 2010
Last Verified: December 2010

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
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action