PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-02-29

Brief Summary

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Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400 tablets from the same drug product batch.

Detailed Description

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Conditions

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Healthy

Keywords

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Pharmacokinetics study

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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PN400

500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

Healthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature

Exclusion Criteria:

Standard inclusion criteria for a study of this nature

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Pozen

Other Identifiers

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PN400-111

Identifier Type: -

Identifier Source: org_study_id