A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers

PHASE4CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

January 1, 2016

Primary Completion Date

March 1, 2016

Study Completion Date

March 11, 2016

Conditions
Infection, Human Immunodeficiency Virus
Interventions
DRUG

Lamivudine

It is a clear, colorless to pale yellow solution with the odour of fruit. It will be provided in a 240 mL bottle with the strength of 10 mg/mL Lamivudine 300 mg (30 mL of solution) will be administered orally to the participants

DRUG

Sorbitol

It is a clear, colorless, odourless solution. It will be available in 3 dosage levels viz;. 3.2 g (low dose), 10.2 g (medium dose) and 13.4 g (high dose) sorbitol total dose.

Trial Locations (1)

66211

GSK Investigational Site, Overland Park

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

ViiV Healthcare

INDUSTRY