Effect of Food on the Pharmacokinetics of Oral Treprostinil

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Hypertension, PulmonaryPulmonary Arterial Hypertension
Interventions
DRUG

Treprostinil diethanolamine

Subjects will each receive a single 1 mg sustained release tablet of treprostinil diethanolamine by mouth within 10 minutes of consuming each of four standardized meals on Study Days 1, 8, 15, and 22.

OTHER

Standardized meals

Each subject will receive one of four different standardized meals of varying caloric and fat content in a randomized sequence such that all subjects will receive all four meals over the course of the study. Each subject will receive one standardized meal for breakfast on Study Days 1, 8, 15, and 22.

Trial Locations (1)

78744

PPD Development, Austin

Sponsors
All Listed Sponsors
lead

United Therapeutics

INDUSTRY