An Open-label Single and Repeat Dose Study to Investigate the Pharmacokinetic Profiles of Tenofovir Disoproxil Fumarate 300 mg in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- area under the concentration-time curve during steady state (AUC(0-τ))
研究概览
简要总结
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.
详细描述
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, single and repeat dose sessions and a follow-up contact.
The screening visit will be conducted up to 28 days prior to the first dose of treatment period 1. Screening assessments will occur as indicated in the Time and Events Table.
Subjects who meet the inclusion/exclusion criteria will be admitted to the study centre on Day -1 to undergo baseline procedures before the single dose session. Study medication will be administered the following morning (Day 1) for the single dose phase. Subjects will be required to fast for at least 8 h (overnight) prior to dosing until 4 h after dosing. Pharmacokinetic samples will be taken until Day 3.
The repeat dose session will begin on Day 4. Subjects will receive a once daily dose of TDF 300 mg in a fasted state each morning for 7 days. Subjects will be required to fast for at least 8 h (overnight) prior to dosing on Day 8 and Day 9, and for at least 8 h (overnight) prior to dosing until 4 h after dosing on Day 10. A trough pharmacokinetic sample will be collected before dosing on Day 8, Day 9 and a series of samples will be taken from Day 10 to Day 12.
Subjects will remain in-house from the evening before dosing (Day -1) until after the final pharmacokinetic sample has been collected on Day 12 and the final safety assessment completed on Day 13. Then subjects will be discharged from the study centre at the Investigator's discretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TDF tablets
Tenofovir disoproxil fumarate tablets
干预措施: TDF tablets (Drug)
结局指标
主要结局
area under the concentration-time curve during steady state (AUC(0-τ))
时间窗: up to 60 hours after repeat dose
AUC(0-τ) during steady state
area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t))
时间窗: up to 60 hours after single dose
AUC(0-t) of single dose
次要结局
- adverse events (AEs)(up to 20 days, from the first dose until the follow-up contact)
- lab assessment(day 13, prior to discharge from hospital)
- vital signs(day 1 pre-dose, day 2, day 3, day 10 pre-dose, day 11, day 12 and day 13 prior to discharge from hospital)
- 12-lead electrocardiogram (ECG) parameters(day 13, prior to discharge from hospital)