Last updated: 11/07/2018 09:36:20
Pharmacokinetic (PK) profiles of tenofovir disoproxil fumarate (TDF) 300 mg in healthy Chinese subjectsPK of TDF
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open-label single and repeat dose study to investigate the pharmacokinetic profiles of tenofovir disoproxil fumarate 300 mg in healthy Chinese subjects
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t))
Timeframe: up to 60 hours after single dose
area under the concentration-time curve during steady state (AUC(0-τ))
Timeframe: up to 60 hours after repeat dose
Secondary outcomes:
adverse events (AEs)
Timeframe: up to 20 days, from the first dose until the follow-up contact
vital signs
Timeframe: day 1 pre-dose, day 2, day 3, day 10 pre-dose, day 11, day 12 and day 13 prior to discharge from hospital
lab assessment
Timeframe: day 13, prior to discharge from hospital
12-lead electrocardiogram (ECG) parameters
Timeframe: day 13, prior to discharge from hospital
Interventions:
Drug: TDF tablets
Enrollment:
14
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Chaoying Hu, Yanmei Liu, Yun Liu, Qian Chen, Wei Wang, Jingying Jia, Shixuan Sun, Chuan Lu, Kai Wu, Jie Li, Jane Dong, Chen Yu, Xuening Li . PharmacokineticsandTolerabilityofTenofovirDisoproxil Fumarate 300mgOnceDaily:AnOpen-Label,Single-and Multiple-Dose StudyinHealthyChineseSubjects. Clin Ther. 2013;35(12):1884-1889.
Medical condition
Hepatitis B, Chronic
Product
tenofovir disoproxil fumarate
Collaborators
Not applicable
Study date(s)
December 2011 to December 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- Healthy, as determined by a responsible and experienced physician
- Male or female between 18 and 45 years of age
- Positive result for hepatitis B, hepatitis C or HIV at screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
Inclusion and exclusion 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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2011-30-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 115515 can be found on the GSK Clinical Study Register.
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