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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PN400

Drug

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

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

Sponsors and collaborators

Lead sponsor

POZEN

Industry

Registry information

Official study title

An Open-Label, 2-Period Pharmacokinetic Study to Evaluate the Intra-Subject Variability in Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400 Tablets

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Jan 23, 2008
Registry last updated: Apr 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed