A Phase I, Pharmacokinetic Trial, in Healthy Asian and Caucasian Volunteers for Investigating the Pharmacokinetic Profiles of Eurartesim™ (40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine (PQ) Phosphate.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- PK: tmax, Cmax, AUC0-12(DHA), AUC0-24(PQ), AUC0-inf, λz, t1/2
研究概览
简要总结
The Study was designed to evaluate the pharmacokinetics of DHA and PQ in healthy volunteers and to assess the effect of ethnicity (Asian vs Caucasian), gender and body weight on the relative bioavailability of DHA and PQ.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian or Asian healthy subjects, Male or female, 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 36 kg.
- •Agreed to use two approved methods of contraception
- •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
- •Pregnant or lactating (females only)
- •Abnormal laboratory test results deemed clinically significant at screening
- •Positive urine drug test or alcohol breath test
- •Acute therapy for a serious infection within 30 days of study entry
- •History of significant drug allergies or significant allergic reactions
- •Had participated in a clinical trial or had received an experimental therapy within 30 days or 10 half-lives of the drug
- •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
Asian Healthy Volunteers
Asian males with a body weight ≤ 65 kg (12 subjects) Asian females with a body weight ≤ 65 kg (12 subjects)
干预措施: Eurartesim (Drug)
Caucasian Healthy Volunteers
Caucasian males with a body weight ≤ 65 kg (12 subjects) Caucasian females with a body weight ≤ 65 kg (12 subjects) Caucasian males with a body weight > 65 kg (24 subjects)
干预措施: Eurartesim (Drug)
结局指标
主要结局
PK: tmax, Cmax, AUC0-12(DHA), AUC0-24(PQ), AUC0-inf, λz, t1/2
时间窗: During the first and last day of drug administration (day 0 and 2) and followed up till Day 90
DHA evaluation: At pre-dose on day Day 0 and Day 2 and then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose. PQ evaluation: At pre-dose Day 0 and then at 1, 2, 3, 4, 5, 6, 8, 12, and 16 hours post-dose; then at pre-dose Day 1 and Day 2 and finally at 1, 2, 3, 4, 5, 6, 8, 12, and 16 hours post-dose on day 2; on Day 3, 4, 5, 7, 14, 21, 28, 42, 56 and 90.
次要结局
- Number of Treatment Emergent Adverse Events (TEAEs)(From Day 0 till Day 90)
- QTc interval prolongation(Day 0, day 3, day 28, day 90)
- Hematology and blood chemistry changes respect to baseline values(Day 0, Day 3, Day 28, Day 90)