Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine
NCT01153386 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2010-08-23
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.
Conditions
Interventions
- DRUG
-
Treprostinil diethanolamine
Treprostinil diethanolamine sustained release oral tablets.
Sponsors & Collaborators
-
United Therapeutics
lead INDUSTRY
Principal Investigators
-
Thomas L Hunt, MD, PhD · PPD Development, LP
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-07-31
- Primary Completion
- 2010-08-31
- Completion
- 2010-08-31
Countries
- United States
Study Locations
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