Study of the Effect of Food on the Pharmacokinetics of DHA and PQP After Single Oral Administration of Eurartesim™ in Healthy Male Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- tmax, Cmax, AUC0-last, AUC0-24 [PQ], and AUC0-inf, λz, t1/2, Cl/F, Vz/F [DHA].
研究概览
简要总结
The study was designed to assess the effect of food on the extent and rate of absorption of Dihydroartemisinin (DHA) and Piperaquine Phosphate (PQP) administered as a fixed dose combination (Eurartesim™).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian healthy males aged between 18 and 50 years(inclusive).
- •Body Mass Index (BMI) between 19.0 kg/m2 and 27.0 kg/m2 inclusive, with a minimum body weight of 75 kg.
- •Agreed to use two approved methods of contraception from Screening and until 90 days after administration of the study drug
- •Had given written informed consent to participate in this study in accordance with local regulations.
排除标准
- •Had received or was anticipated to receive a prescription medication within 14 days prior to the start of dosing or an over-the-counter medicine 48 hours prior to the start of dosing.
- •Abnormal laboratory test results deemed clinically significant by the Medical Officer.
- •Positive urine drug test (e.g. opiates and cannabinoids) or alcohol breath test.
- •History of significant drug allergies or significant allergic reaction.
- •Receipt of blood or blood products, or loss or donation of 450 mL or more of blood within 90 days before the first dose administration.
研究组 & 干预措施
fed treatment
18 healthy volunteers administered with a single dose of Eurartesim
干预措施: Eurartesim (Drug)
Fasted Treatment
18 healthy volunteers treated with a single dose of Eurartesim
干预措施: Eurartesim (Drug)
结局指标
主要结局
tmax, Cmax, AUC0-last, AUC0-24 [PQ], and AUC0-inf, λz, t1/2, Cl/F, Vz/F [DHA].
时间窗: from the day of study drug administration, till Day 7 follow-up
Blood samples for determination of plasma DHA were collected at the following times: At pre-dose Day 0 and then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose. Blood samples for determination of plasma PQ were collected at the following times: At pre-dose Day 0 and then at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose; on Day 1, 2, 3, 4, 5 and 7.
次要结局
- Number of Treatment Emergent Adverse Events(Day 0 and till Day 30 follow-up)
- Hematology and blood chemistry changes respect to baseline values(Day 0, day 2, day 30)
- QTc interval prolongation(Day 0, day 2, day 30)