TCTR20170907002已完成未知
Randomized Open-Label, Single-Dose, Cross-Over Study to Evaluate the Bioequivalence of a New Parenteral Formulation of Artesunate with the Currently Used Formulation in Healthy Adult Thai Subjects.
Guilin Pharmaceutical (Shanghai) Co., Ltd.0 个研究点目标入组 72 人开始时间: 2017年9月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1)Healthy male and female subjects aged 18-55 years
- •2)Body mass index of 18-25 kg/m2
- •3) No evidence of underlying disease, physically or mentally disabled or clinically significant abnormal finding during screening and/or medical history examination
- •4)A female is eligible to participate in this study if she is
- •â€¢ of non-childbearing potential including pre-menopausal females
- •with documented (medical report verification) hysterectomy or
- •double oophorectomy, or
- •â€¢ of non-childbearing potential including post-menopausal females
- •defined as 12 months of spontaneous amenorrhea or 6 months of
- •spontaneous amenorrhea with serum follicle stimulating hormone
- •levels >40 mIU/mL or 6 weeks post-surgical bilateral oophorectomy
- •with or without hysterectomy, or
- •â€¢ of childbearing potential, but has a negative serum pregnancy test
- •at screening and prior to study drug administration in each
- •period, and willingness to abstain from sexual intercourse or
- •agrees to using effective contraceptive methods (e.g.,
- •intrauterine device, hormonal contraceptive drug, tubal ligation
- •or female barrier method with spermicide) during the study period
- •until completion of the follow-up procedures
- •5)A male is eligible to enter and participate in this study if he agrees to abstain from sexual intercourse with females of childbearing potential or is willing to use a condom/spermicide during the study until completion of the follow-up procedures
- •6)Normal ECG with Fridericia-corrected QT (QTcF) and Bazett-corrected QT (QTcB) intervals < 450 msec
- •7)Willing to participate in this study and sign the Informed Consent Form
排除标准
- •1)Any history of hypersensitivity to artesunate or known hypersensitivity to any component of the formulations
- •2)History of abnormal bleeding after minor injury or prolong hematoma following the intramuscular injection
- •3)Family history of any bleeding tendency
- •4)Platelet < 150,000 /µl
- •5)PT or PTT > upper normal limit or INR > 1.5
- •6)AST or ALT > 1.5 ULN
- •7)Creatinine clearance (CLcr) <70 mL/min as determined by Cockcroft-Gault equation
- •8)Personal and/or family history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, risk factors for torsades de points (heart failure, hypokalaemia), or with a family history of sudden cardiac death
- •9)Administration of a known drug that can cause damage to organs or other medicinal products known to prolong the QT interval (e.g. mefloquine, halofantrine, lumefantrine, chloroquine, quinine, and piperaquine) in the preceding 3 months prior to the start of the study
- •10)Participation in a clinical trial or receiving a prescription drug, non-prescription drug or a new chemical entity within 30 days, 5 half-lives or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication
- •11)Donation of blood to the extent that participation in the study would result in more than 300 mL blood donated within a 30-day period. Plasma or blood donation during the study is not acceptable
- •12)HIV, HBV, or HCV positive
- •13)Malaria positive
- •14)History of alcohol or substance abuse or dependence
- •15)Unwillingness to abstain from ingesting alcohol within 48 hours prior to the first dose of study medication until collection of the final pharmacokinetic sample during each regimen
- •16)Receiving any form of anticoagulant within 14 days prior to start study drug, plan to receive any form of anticoagulant while participating in the study.
研究者
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