NCT02705807 - Evaluation of a New Thermostable Formulation of FLOLAN in Japanese Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions

Cardiovascular Disease

Interventions

DRUG

FLOLAN injection with currently marketed diluent

FLOLAN injection (epoprostenol 0.5 or 1.5) prepared with the currently marketed diluent (epoprostenol sodium+ powder of hydrogen \[pH\] 10.2 - 10.8 diluent) for Injection.

DRUG

FLOLAN injection with reformulated diluent

FLOLAN injection (epoprostenol 0.5 or 1.5) prepared with the reformulated diluent (epoprostenol sodium + pH 11.7 - 12.3 diluent) for Injection.

Trial Locations (1)

701-1192

GSK Investigational Site, Okayama