To Assess the Relative Bioavailability (BA) of TRIUMEQ® and Dolutegravir and Lamivudine (DTG/3TC) Pediatric Dispersible Tablet Formulations in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 26, 2018

Primary Completion Date

April 28, 2018

Study Completion Date

April 28, 2018

Conditions
HIV Infections
Interventions
DRUG

Treatment A

TRIUMEQ (Adult) administered as a, single dose, fixed dose combination (FDC) tablet - DTG 50 mg/ABC 600 mg/3TC 300 mg as 1 conventional tablet, orally as direct-to-mouth.

DRUG

Treatment B

TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet - DTG 5 mg/ABC 60 mg/ 3TC 30 mg, orally as 10 dispersible tablets

DRUG

Treatment C

TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet - DTG 5 mg/ABC 60 mg/3TC 30 mg, orally as direct-to-mouth.

DRUG

Treatment D

"DTG and 3TC (Adult), administered as a, single dose, Single dose, 1 tablet DTG (50 mg) and~1 tablet 3TC (300 mg), orally as direct-to-mouth."

DRUG

Treatment E

DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet - DTG 5 mg/3TC 30 mg, orally as 10 dispersible tablets.

DRUG

Treatment F

DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet - DTG 5 mg/3TC 30 mg, orally as direct-to-mouth.

Trial Locations (1)

78744

GSK Investigational Site, Austin

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Pharmaceutical Product Development (PPD), Inc

UNKNOWN

lead

ViiV Healthcare

INDUSTRY