NCT00907400

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

4 months

First QC Date

May 21, 2009

Last Update Submit

December 8, 2010

Conditions

Healthy

Keywords

Phase 1Healthy VolunteerHealthy Volunteer Study

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    pre-dose and multiple times post-dose

Secondary Outcomes (1)

  • Safety

    Throughout study

Study Arms (2)

1

EXPERIMENTAL

PN400

Drug: PN400

2

ACTIVE COMPARATOR

Naprosyn E

Drug: Naproxen

Interventions

PN400DRUG

oral tablet

Also known as: VIMOVO™
1
NaproxenDRUG

oral tablet

Also known as: Naprosyn E
2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Luleå, Sweden

Location

Research Site

Uppsala, Sweden

Location

MeSH Terms

Interventions

Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Mark Sostek, MD

    AstraZeneca

    STUDY DIRECTOR

  • Aslak, Rautio, MD

    Quintiles Hermelinen

    PRINCIPAL INVESTIGATOR

  • Elisabeth Eden, MD

    Quintiles AB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 21, 2009

First Posted

May 22, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

December 10, 2010

Record last verified: 2010-12

Locations

SE(2)