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

NCT ID: NCT00907400

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Phase 1 Healthy Volunteer Healthy Volunteer Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

PN400

Group Type EXPERIMENTAL

PN400

Intervention Type DRUG

oral tablet

2

Naprosyn E

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

oral tablet

Interventions

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PN400

oral tablet

Intervention Type DRUG

Naproxen

oral tablet

Intervention Type DRUG

Other Intervention Names

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VIMOVO™ Naprosyn E

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Mark Sostek, MD

Role: STUDY_DIRECTOR

AstraZeneca

Aslak, Rautio, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles Hermelinen

Elisabeth Eden, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles AB

Locations

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Research Site

Luleå, , Sweden

Site Status

Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudraCT No 2009-011738-87

Identifier Type: -

Identifier Source: secondary_id

D1120C00024

Identifier Type: -

Identifier Source: org_study_id