ACTRN12610000178044招募中1 期
A phase 1 pharmacokinetic trial in healthy Asian and Caucasian volunteers, investigating the pharmacokinetic profile of an Anti-Malarial drug - 40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine Phosphate (PQP).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •1. Male or female, aged between 18 and 50 years (inclusive).
- •2. Caucasian or Asian (excluding Indian sub-continent or Middle Eastern origin).
- •3. Healthy subjects - healthy subjects are defined as individuals who are free from clinically
- •significant illness or disease as determined by their medical/surgical history, physical
- •examination (including height and weight), vital signs, 12-lead ECG and clinical laboratory
- •determinations.
- •4. Adequate venous access in the left or right arm to allow collection of a number of blood
- •5. Body Mass Index (BMI) between 19.0 kg/m2 and 27.0 kg/m2 inclusive, with a minimum
- •body weight of 36 kg.
- •6. Agrees to use two approved methods of contraception (excluding post menopausal females
- •and males and females who underwent surgical sterilization at least six months prior to
- •dosing) from Screening and until 90 days after administration of the study drug. Methods
- •of contraception for use by the subject or partner (as applicable) may include condom,
- •approved birth control pills, patches, implants or injections, diaphragm with vaginal
- •spermacide, an IUD (intra uterine device).
- •7. Have given written informed consent to participate in this study in accordance with local
- •regulations.
排除标准
- •1. Have received or is 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.
- •2. Any condition that would interfere with drug absorption (e.g. chronic diarrhoea).
- •ST3073/ST3074-DM09-007
- •Final Version 3.0 of 03 Feb 2010 18/61
- •3. Be pregnant or lactating (females only).
- •4. Abnormal laboratory test results deemed clinically significant by the Medical Officer
- •(Principal Investigator or medically qualified nominee).
- •5. Evidence of significant renal insufficiency, as indicated by an estimated creatinine
- •clearance using the Cockcroft-Gault formula of less than 75 mL/min at Screening.
- •6. As a result of medical review, physical examination (including height and weight) or
- •Screening investigations, the Medical Officer considers the subject unfit for the study.
- •7. Positive urine drug test or alcohol breath test.
- •8. History or clinical evidence of oral, cardiovascular, cerebrovascular, haematological,
- •gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric or skin
- •disorder, which in the opinion of the Investigator would compromise the participant’s
- •safety or other aspects of the study.
- •9. Acute therapy for a serious infection within 30 days of study entry.
- •10. History of significant drug allergies or significant allergic reaction or currently suffers from
- •clinically significant systemic allergic disease.
- •11. Positive Screening test for Hepatitis B surface antigen or Hepatitis C antibody or HIV
- •(human immunodeficiency virus).
- •12. Have participated in a clinical trial or have received an experimental therapy within 30
- •days or 10 half-lives of the drug, whichever is the longer, prior to dosing.
- •13. 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.
- •14. Regularly drink more than four (4) units (for males) and two (2) units (for females) of
- •alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit).
- •15. Unwilling to abide by the study restrictions listed in Section 8.3, including refraining from
- •smoking during the confinement period.
研究者
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