NCT01153386

Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine

An Evaluation of the Pharmacokinetic Linearity and Comparative Bioavailability of a Single Oral Dose of 0.5 mg, 1 mg and 2.5 mg UT-15C (Treprostinil Diethanolamine) SR Tablets in Healthy Volunteers in the Fed State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will compare the bioavailability and pharmacokinetics of the 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine tablet strengths in healthy volunteers.

Detailed description

This study was designed to assess the pharmacokinetic linearity and comparative bioavailability of UT-15C SR (treprostinil diethanolamine) following the administration of a single tablet containing 0.5 mg, 1 mg and 2.5 mg UT-15C in healthy volunteers.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Treprostinil diethanolamine	Treprostinil diethanolamine sustained release oral tablets.

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-06-30
• Last updated: 2010-08-23

Locations

1 site across 1 country: United States