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Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil

NCT00963027 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-03-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics.

Conditions

Interventions

DRUG

Treprostinil diethanolamine

Subjects will each receive a single 1 mg sustained release tablet of treprostinil diethanolamine by mouth immediately following breakfast before and after repeated daily dosing with esomeprazole.

DRUG

Esomeprazole

Each subject will receive a single 40 mg capsule of esomeprazole by mouth in the morning for seven days.

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • Aziz Laurent, MD · PPD Development, LP

Study Design

Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00963027 on ClinicalTrials.gov