A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin

A Phase I Prospective, Randomized, Double-blind, Placebo-controlled Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN 400 and Low Dose Aspirin

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01094483

Enrollment

Registered

2010-03-29

Start date

2010-03-31

Completion date

2010-05-31

Last updated

2010-12-07

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

Conditions

Platelet Inhibition

Keywords

Thromboxane B2

Brief summary

The primary hypothesis of this study is that concomitant multiple-dose administration of PN 400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose aspirin (81 mg), as measured by serum thromboxane B2 inhibition.

Interventions

DRUGPN400

naproxen 500 mg/esomeprazole 20 mg oral tablet

DRUGASA

Asprin 81 mg enteric coated tablet

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Stable without clinically significant disease

Exclusion criteria

* Use of NSAID within 2 weeks * Type 1 or 2 DM * GI disorder

Design outcomes

Primary

Measure	Time frame
Pharmacodynamic: Mean percent inhibition of serum thromboxane B2	measured on the morning of Day 6 (Period 1), and 24 hours after the Day 10 morning dose of aspirin (ie, Day 11) in Period 2
Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events	during approx 6 week study period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026