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

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.

Timeline

Start

2010-08

Primary completion

2010-08

Completion

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Drugs

Indications