ACTRN12618000968279已完成1 期
A two-period, open-label, randomized, parallel-group, partial cross-over study to evaluate the relative bioavailability and pharmacokinetics of two lumefantrine formulations in comparison to a reference formulation in healthy volunteers
ovartis Pharmaceuticals Corporation0 个研究点目标入组 42 人开始时间: 2018年6月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Written informed consent must be obtained prior to participation in the study.
- •Healthy male and female subjects of non-childbearing potential aged 18 to 55 years included, and in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening.
- •At Screening, vital signs (systolic and diastolic blood pressure and
- •pulse rate) will be assessed in the sitting position after the subject has rested for at least 5 minutes, and again after 3 minutes in the standing position at Screening only. Sitting vital signs will be captured for the duration of the study and should be within the normal range:
- •-oral body temperature between 35.0°C to 37.5°C
- •-systolic blood pressure, 90 to 139 mmHg
- •-diastolic blood pressure, 40 to 89 mmHg
- •-pulse rate, 40 to 90 bpm
- •Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 30 kg/m2. BMI = body weight (kg)/(height [m])2.
- •Able to communicate well with the Investigator, to understand and
- •comply with the requirements of the study.
排除标准
- •Women of childbearing potential, defined as all women physiologically capable of becoming pregnant. Women are considered postmenopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, a woman will only be considered not of childbearing potential if her reproductive status has been confirmed by follow-up hormone level assessment.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test.
- •Sexually active males unwilling to use a condom during intercourse or unwilling to refrain from sperm donation for greater than or equal to 4 weeks (28 days) after last dosing. A condom is required for all sexually active male participants to prevent them from either fathering a child OR donating sperms.
- •Use of any prescription drugs or over-the-counter medication (vitamins, herbal supplements, and dietary supplements) within 4 weeks or 5 times the terminal half-life of each drug prior to dosing.
- •Use of other investigational drugs at the time of enrollment, or within
- •30 days, whichever is longer; or longer if required by local regulations.
- •History of hypersensitivity to the study drug or any of its excipients or to drugs of similar chemical classes.
- •A past medical history of clinically significant cardiac or ECG
- •abnormalities (including arrhythmias) or a family history (grandparents, parents and siblings) of a prolonged QT interval syndrome, defined as a corrected QT interval, by Fridericia formula of > 450 msec of males and > 460 msec for females at Screening or first Baseline.
研究者
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