15
Participants
Start Date
July 31, 2014
Primary Completion Date
September 30, 2014
Study Completion Date
September 30, 2014
Dolutegravir Pediatric Granules
Dolutegravir pediatric granules are supplied as 40 grams bulk bottles containing 0.4% weight by weight of dolutegravir to be reconstituted with 73 mL of purified water to yield a dolutegravir concentration of 1.6 milligram / millilitre. 12.5 mL of reconstituted granules contain 20 mg DTG
Dolutegravir Dispersible Tablet
Dolutegravir is available as 5mg dispersible tablets and can be administered as 4 tablets dispersed in 12.5 mL LMC water and consumed immediately or 4 tablets dispersed in 12.5 mL CONTREX mineral water and consumed immediately or 4 tablets dispersed in 12.5 mL LMC water, allow to stand at room temperature for 30 mins, re-suspend mixture and consumed or 4 tablets dispersed in 12.5 mL CONTREX mineral water, allow to stand at room temperature for 30 mins, re-suspend mixture and consumed
GSK Investigational Site, Overland Park
Lead Sponsor
Collaborators (1)
GlaxoSmithKline
INDUSTRY
ViiV Healthcare
INDUSTRY