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

POZEN18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

PN400DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pharmacokinetic profile following dosing with PN400

Time frame: 24-hour PK on Day 1 & Day 10 of each treatment period

Secondary Outcomes

To evaluate the safety of PN400

Time frame: Day 1-10 of each treatment period

Data from ClinicalTrials.gov

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