Status:
COMPLETED
Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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. T...
Detailed Description
This will be an open-label, single group, single and repeat dose study with no placebo control in healthy Chinese subjects conducted at a single centre. The study will include a screening visit, singl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 5 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01480622
Start Date
December 5 2011
End Date
December 30 2011
Last Update
June 14 2017
Active Locations (1)
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1
GSK Investigational Site
Shanghai, China, 200030