NCT02751294 - A Study to Assess the Effects of Dissolution Profile on the Pharmacokinetics of Single Oral Doses of Tafenoquine Tablets and Tafenoquine Stable Isotope Labelled Solution | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions

Malaria, Vivax

Interventions

DRUG

Tafenoquine Control

It will be supplied as a dark pink, capsule-shaped, film-coated tablet plain on both sides containing 150 mg tafenoquine

DRUG

Tafenoquine dissolution profile X

"It will be supplied as a dark pink, capsule-shaped, film-coated tablet plain on both sides containing 150 mg tafenoquine and will be intermediate aged TQ Product."

DRUG

Tafenoquine SIL

It will be compounded at site and will be administered as 0.3 mg/mL (100mL to be dosed, equivalent to 30 mg) aqueous Solution of SIL Tafenoquine.

Trial Locations (1)

21225

GSK Investigational Site, Baltimore