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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00761501
First received: September 26, 2008
Last updated: December 7, 2010
Last verified: December 2010

September 26, 2008
December 7, 2010
September 2008
December 2008   (final data collection date for primary outcome measure)
Pharmacokinetics [ Time Frame: pre-dose and multiple times post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00761501 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E
Phase I, Open-label, Randomized, 3-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E in Healthy Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Volunteer
  • Drug: PN400
    Oral
    Other Name: VIMOVO™
  • Drug: Naproxen (Proxen S)
    Oral
    Other Name: Proxen S
  • Drug: Naproxen (Naprosyn E)
    Oral
    Other Name: Naprosyn E
  • Experimental: 1
    Intervention: Drug: PN400
  • Active Comparator: 2
    Intervention: Drug: Naproxen (Proxen S)
  • Active Comparator: 3
    Intervention: Drug: Naproxen (Naprosyn E)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00761501
D1120C00001
No
Mark Sostek, MD, Medical Science Director, Development Projects, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Study Director: Mark Sostek, MD AstraZeneca
Principal Investigator: Aslak Rautio, MD Quintiles Hermelinen
Principal Investigator: Wolfgang Kuhn, MD Quintiles Phase I Services
AstraZeneca
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP