A Bioavailability Study Comparing Treprostinil Diethanolamine Oral Tablets and Oral Solution in Healthy Volunteers
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.