Phase I Study to Evaluate Bioavailability of Naproxen as... | NCT00761501

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

NCT00761501

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 9, 2010Estimated

Enrollment

38Estimated

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

PN400
Naproxen (Proxen S)
Naproxen (Naprosyn E)

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Sep 26, 2008

First Submission Date that Met QC Criteria

Sep 26, 2008

First Posted Date

Sep 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2010

Last Update Posted Date

Dec 9, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Drug: PN400
2	Active Comparator	Drug: Naproxen (Proxen S)
3	Active Comparator	Drug: Naproxen (Naprosyn E)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PN400	Drug	Oral	1	VIMOVO™

Measure	Description	Time Frame
Pharmacokinetics		pre-dose and multiple times post-dose

Measure	Description	Time Frame
Safety		Throughout study

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Sostek, MD	AstraZeneca	Study Director
Aslak Rautio, MD	Quintiles Hermelinen	Principal Investigator
Wolfgang Kuhn, MD	Quintiles Phase I Services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Luleå			Sweden
Research Site

Intervention Browse Module

MeSH Terms

ID	Term
D009288	Naproxen

Ancestor Terms

ID	Term
D009280	Naphthaleneacetic Acids
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided