Single Oral Dose Study of Atovaquone/Proguanil Hydrochloride Combination Tablets and Atovaquone Suspension
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
This study will be a single-center, phase I, randomized, open, in fed condition, parallel,
single dose study to evaluate the pharmacokinetics and the safety, tolerability of
Atovaquone/proguanil combination tablets and atovaquone suspension in Japanese healthy male
subjects.
Serial blood samples will be collected for the determination of the plasma concentration of
atovaquone, proguanil and cycloguanil after dosing of atovaquone 1000mg/proguanil 400 mg and
the plasma atovaquone concentration of atovaquone 750 and 1500 mg. Safety assessments will be
performed for each treatment group.
CYP2C19 contribute to proguanil metabolism. CYP2C19 genotype will be determined in
atovaquone/proguanil dosing group.
Phase:
Phase 1
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Atovaquone Atovaquone, proguanil drug combination Proguanil