NCT01172496

A Bioavailability Study Comparing Treprostinil Diethanolamine Oral Tablets and Oral Solution in Healthy Volunteers

A Comparative Bioavailability Study of UT-15C SR (Treprostinil Diethanolamine, Sustained Release) Oral Tablets and UT-15C (Treprostinil Diethanolamine) Administered as an Oral Solution in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This single center, open label, randomized, two-period, two-sequence cross-over study is designed to evaluate the relative bioavailability of a treprostinil diethanolamine 1 mg tablet in reference to treprostinil diethanolamine 1 mg oral solution (administered as four 0.25 mg doses every 2 hours for a 1 mg total dose) in twenty-four healthy volunteers. Other secondary outcomes of interest include assessment of pharmacokinetic parameters of treprostinil diethanolamine 1 mg tablets and a treprostinil diethanolamine 1 mg oral solution administered as four doses (0.25 mg every 2 hours for a 1 mg total dose) and evaluation of the safety and tolerability of each treatment regimen.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	treprostinil diethanolamine	Subjects will be administered a 1 mg dose of treprostinil diethanolamine as a single tablet, and treprostinil diethanolamine oral solution 0.25 mg dose every 2 hours for four doses (1 mg total).

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-08-01
• First posted: 2010-07-29
• Last updated: 2010-10-13

Locations

1 site across 1 country: United States