Pharmacokinetics of treprostinil sodium administered by 28-day chronic continuous subcutaneous infusion.

The objective of this study was to assess the pharmacokinetics and safety of treprostinil sodium administered as a 28-day continuous subcutaneous infusion at escalating infusion rates of 2.5 to 15 ng/kg/min in normal subjects. Fourteen healthy adult volunteers received a 28-day continuous sub-cutaneous infusion of treprostinil at escalating infusion rates of 2.

Absolute bioavailability and pharmacokinetics of treprostinil sodium administered by acute subcutaneous infusion.

The objective of this study was to evaluate the absolute bioavailability and acute pharmacokinetics of treprostinil sodium administered by continuous, short-term subcutaneous infusion in normal subjects. Fifteen healthy volunteers received treprostinil via an intravenous infusion at 15 ng/kg/min over 150 minutes, followed by a 5- to 7-day washout and a subcutaneous infusion at the same rate administered over 150 minutes. Serial plasma samples were collected predosing, during dosing, and postdosing, and plasma treprostinil concentration levels were measured by a validated liquid chromatography atmospheric pressure ionization tandem mass spectrometry (LC/MS/MS) method with a lower limit of quantitation (LLOQ) of 25 pg/mL.

Effect of continuous subcutaneous treprostinil therapy on the pharmacodynamics and pharmacokinetics of warfarin.

Treprostinil sodium was recently approved in the United States for continuous subcutaneous infusion in the treatment of pulmonary arterial hypertension (PAH). Anticoagulation with warfarin is recommended in PAH therapy. Given the likelihood for treprostinil and warfarin coadministration, a single-blind, controlled, crossover study was conducted to evaluate the effect of treprostinil infusion on the pharmacodynamics and pharmacokinetics of a single dose of warfarin.