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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00599404

Enrollment

Registered

2008-01-23

Start date

2008-01-31

Completion date

2008-02-29

Last updated

2008-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacokinetics study

Brief summary

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

Interventions

DRUGPN400

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic profile following dosing with PN400	24-hour PK on Day 1 & Day 10 of each treatment period

Secondary

Measure	Time frame
To evaluate the safety of PN400	Day 1-10 of each treatment period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026