Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese Subjects

• Status: Completed
• Trial end date: 2011-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

• Healthy, as determined by a responsible and experienced physician

• Male or female between 18 and 45 years of age

• Body weight >50 kg (110 lbs) for males or >45 kg (100 lbs) for females, and body mass index (BMI) between 19.0 and 24.0 kg/m2

Exclusion Criteria:

• Positive result for hepatitis B, hepatitis C or HIV at screening

• Current or chronic history of liver disease, or known hepatic or biliary abnormalities

• Positive urine drug screen and breath alcohol test at screening or prior to dosing

• Lactating females