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

AstraZeneca40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Platelet Inhibition

Interventions

PN400DRUG

naproxen 500 mg/esomeprazole 20 mg oral tablet

ASADRUG

Asprin 81 mg enteric coated tablet

PlaceboDRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Stable without clinically significant disease Exclusion Criteria: * Use of NSAID within 2 weeks * Type 1 or 2 DM * GI disorder

Locations (1)

Research Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Pharmacodynamic: Mean percent inhibition of serum thromboxane B2

Time frame: 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

Time frame: during approx 6 week study period

Data from ClinicalTrials.gov

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