31
Participants
Start Date
November 23, 2016
Primary Completion Date
March 1, 2019
Study Completion Date
March 4, 2019
IH Oxytocin
Oxytocin will be supplied as colourless and clear hard capsule with powder blend for inhalation with unit dose strength 400 mcg and 200 mcg. It will be administered using ROTAHALER dry powder inhaler (DPI).
IM Oxytocin
Oxytocin will be supplied for solution for infusion in 1ml ampoule containing colourless and clear sterile solution with unit dose strength 5 I.U./mL, or 10 I.U./mL for IM administration
IV Oxytocin
Oxytocin will be supplied as solution for infusion in 1ml ampoule containing colourless and clear sterile solution to be administered as a 30-second IV bolus with unit dose strength 5 I.U./mL, or 10 I.U./mL.
ROTAHALER
ROTAHALER DPI device is a high airflow resistance capsule-based inhaler. It will be used to deliver IH oxytocin
GSK Investigational Site, Clayton
GSK Investigational Site, Cambridge
GSK Investigational Site, Cambridge
Lead Sponsor
InVentiv Clinique
INDUSTRY
Monash University
OTHER
GlaxoSmithKline
INDUSTRY