Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese Subjects
Status:
Completed
Trial end date:
2011-12-30
Target enrollment:
Participant gender:
Summary
This study will evaluate the pharmacokinetic profile of tenofovir disoproxil fumarate (TDF)
300 mg in Chinese subjects to support the registration of this compound in the People's
Republic of China. This will be an open-label, single group, single and repeat dose study
without placebo in healthy male and female subjects. Pharmacokinetic sampling to enable
measurement of plasma concentrations of tenofovir will be conducted over a 60-h period after
the single dose and at steady state. The duration of the study will be approximately 7 weeks
from screening to follow-up.