PPD Development
Austin, Texas, 78744, United States
NCT Number: NCT01165476
The purpose of this study is to compare the bioavailability of a single 1mg dose of treprostinil diethanolamine sustained release (SR) tablets manufactured by two independent facilities.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Austin, Texas, 78744, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
sustained release tablets. One 1mg tablet per period. Two total doses.
Time frame: 36 hours
Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 1mg treprostinil diethanolamine collecting pre and post-dose levels to 36 hours.
Time frame: Days 0, 7 and 9
Time frame: From signing of ICF to end of study
United Therapeutics
Industry
An Evaluation of the Comparative Bioavailability of a Single Oral Dose of 1mg UT-15C (Treprostinil Diethanolamine) SR Tablets Manufactured by Two Independent Facilities Administered to Healthy Volunteers in the Fed State
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