KCT0001104进行中（未招募）未知
Phase I, open-label, cross-over study to investigate the relative bioavailability of Pyramax(pyronaridine-artesunate) in tablet and granule formulations, in healthy volunteers
Shin Poong Pharm0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 45(Year)（—）
- 性别
- All
入选标准
- •1.Healthy male and/or female subjects between the ages of 20 and 45 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- •2.Weight between 50 kg and 80 kg and Body Mass Index (BMI) calculated using Quetelet’s Index [weight(kg)/height (m2)] between 18.5 to 27 kg/m2;
- •3.An informed consent document signed and dated by the subject (prior to any study activities, including discontinuation of any prohibited medications)
- •4.Strictly normal values of ALT, AST, and bilirubin, and normal or abnormal but clinically insignificant results of the other blood and urine laboratory parameters at screening.
- •5.Female subjects of non-childbearing potential [i.e., physiologically incapable of becoming pregnant, including any female who was post-menopausal (i.e., one year without menses) or who has undergone sterilization (via hysterectomy or bilateral tubal ligation)]
- •6.Female subjects of childbearing potential with a negative urine pregnancy test at screening, and a negative pregnancy blood test on admission, and who :
- •- agree to double barrier method of contraception for 4 weeks before first study drug administration and throughout the entire study follow up period, or
- •- whose partner has undergone vasectomy and has been negative for sperm for at least 6 months
- •7.Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •1.Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, acute QTc interval greater or equal to 450 mseconds), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including head trauma)
- •2.Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins
- •3.Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab)
- •4.Seropositive HIV antibody, seropositive syphilis [Syphilis reagin test (+)]
- •5.Previous exposure to pyronaridine-artesunate (Pyramax)
- •6.Present or recent history (last two years) of tobacco abuse (=10 cigarettes/day)
- •7.Known or suspected alcohol abuse or illicit drug use up to 5 years before the study start or positive findings on urine drug screen
- •8.Intake of alcoholic beverages or caffeine-containing food or beverages, such as coffee, tea, chocolate, or cola, 48 hours before study drug administration
- •9.Intake of grapefruit, Seville oranges or products containing these from 72 hours before the start of study drug administration
- •10.Gilbert’s disease
- •11.Use of over-the-counter (OTC) medications, including vitamins, analgesics, antipyretics or antacids within 7 days before study drug administration
- •12.Use of prescription medications within 14 days before the start of study drug administration or required chronic use of any prescription medication
- •13.Use of enzyme-altering agents (e.g., barbiturates, phenothiazines, cimetidine, etc.) within 30 days before the start of study drug administration
- •14.Plasma donation within 60 days before the start of study drug administration
- •15.Blood donation of 500 mL or more within 60 days before the start of study drug administration
- •16. Participation AND having had drug administration in any other clinical study within 60 days before start of study drug administration
研究者
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