A Study to Evaluate the Effects of Calcium Carbonate and Ferrous Fumarate on Pharmacokinetics of Dolutegravir in Healthy Adult Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Infection, Human Immunodeficiency Virus
Interventions
DRUG

Dolutegravir 50 mg

One tablet ( 50 mg) will be administered orally as a single dose in each period per the random code

DRUG

Calcium Carbonate 1200 mg

Two tablets (2 X 600 mg) will be administered orally as a single dose in three out of four periods to Cohort 1 only per the random code. Calcium carbonate will be given in fasted state, fed state and 2 hours before dolutegravir administration.

DRUG

Ferrous Fumarate 324 mg

One tablet (324 mg) will be administered orally as a single dose in three out of four periods to Cohort 2 only per the random code. Ferrous fumarate will be given in fasted state, fed state and 2 hours before dolutegravir administration.

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

ViiV Healthcare

INDUSTRY

NCT01762995 - A Study to Evaluate the Effects of Calcium Carbonate and Ferrous Fumarate on Pharmacokinetics of Dolutegravir in Healthy Adult Subjects | Biotech Hunter | Biotech Hunter