NCT02493738已完成1 期
A Phase I Single-Center, Randomized, Open-label, Single Dose, Crossover Study in Korean Healthy Male Volunteers to Evaluate Pharmacokinetics of Lozanoc and Sporanox
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Study Objectives:
- To evaluate the pharmacokinetics (PK) of orally administered Lozanoc under fasted and fed condition in healthy male subjects
- To compare the pharmacokinetics (PK) of orally administered Lozanoc and Sporanox under fed condition in healthy male subjects
- To evaluate the safety and tolerability of single oral dose of Lozanoc and Sporanox in Korean healthy male subjects
详细描述
Phase I Study divided into 3 parts written as bellows.
Part I. Lozanoc 50mg single dose under fed condition vs Part 2. Lozanoc 50mg single dose under fasted condition vs Part 3. Sporanox 100mg single dose under fed condition
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Korean male volunteers in the age between 19 and 50 years old (inclusive)
- •Subject who are able to give signed informed consent
- •Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighting at least 50kg
- •Subject who are considered
- •Pre-study physical examination with no clinically significant abnormalities
- •No clinically significant medical history
- •Vital signs were to be within reference ranges, or if outside of the range, not deemed clinically significant in the opinion of the Investigator
- •90 mmHg ≤ systolic blood pressure (sitting position) ≤ 140mmHg
- •50 mmHg ≤ diastolic blood pressure (sitting position) ≤ 90 mmHg
- •Pre-study clinical laboratory findings were to be within reference range, or if outside of the range, not deemed clinically significant in the opinion of the Investigator
- •No clinically significant abnormalities in 12-lead ECG results
- •Agree to continue to use at least two accepted methods of birth control and not to donate sperm for at least 1 days before the first dosing, during the course of the study and for a period of 90days following the last dosing.
- •Acceptable methods of birth control are: female (sexual partner) hormonal contraceptives; intrauterine device; surgical sterility at least 6 months prior to screening (Ex. hysterectomy, bilateral oophorectomy, and/or tubal ligation); use diaphragm; use condom; or spermicide
排除标准
- •Subjects will be excluded if they meet any of the following criteria:
- •History of allergy or sensitivity to any drug, including any prior serious adverse reaction to antifungal agent(s)
- •History of congestive heart failure or Patients with ventricular dysfunction such as congestive heart failure
- •Undergone surgery or who have a medical condition, that in the judgment of the Investigator, may affect absorption, distribution, metabolism or elimination of the drug product
- •Participated in a previous clinical trial within 90 days prior to screening visit
- •Donated blood or had a significant loss of blood within 60 days prior to screening visit
- •Special diet or substantial changes in eating habits within 30 days prior to screening visit
- •Use of any prescription medication within 14 days before screening visit
- •Use of any other OTC medication within the 7 days before screening visit
- •History of smoking within 3 months prior to screening visit
- •Have a recent history (within 2 years prior to the screening visit) of alcohol or drug abuse or a positive screen for drugs of abuse at screening
- •Positive blood screen for HIV or hepatitis B or C or syphilis
- •Clinically important abnormal hepatic function test (AST, ALT greater than 2 fold of reference upper limit (ULN), or total bilirubin greater than 1.5 x ULN)
- •Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
研究组 & 干预措施
Lozanoc 50mg
Experimental
Lozanoc 50mg, oral administration
干预措施: Lozanoc 50mg (Drug)
Sporanox 100mg
Active Comparator
Sporanox 100mg, oral administration
干预措施: Sporanox 100mg (Drug)
结局指标
主要结局
Cmax
时间窗: 0~120 hour after medication
次要结局
- tmax(0~120 hour after medication)
- AUCinf(0~120 hour after medication)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1017-1" and Co-administration of "BR1017-1A" and "BR1017-1B"Essential HypertensionPrimary HypercholesterolemiaNCT06184269Boryung Pharmaceutical Co., Ltd58
已完成
1 期
Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837HealthyNCT00878618AstraZeneca36
已完成
1 期
Study of M5049 in CLE and SLE ParticipantsSystemic Lupus ErythematosusCutaneous Lupus ErythematosusNCT04647708Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany25
已完成
1 期
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015 and Co-administration of BR1015-3 and BR1015-2 Under Fasting ConditionsEssential HypertensionNCT06744426Boryung Pharmaceutical Co., Ltd60
已完成
1 期
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015 and Co-administration of BR1015-1 and BR1015-2 Under Fasting ConditionsEssential HypertensionNCT06744127Boryung Pharmaceutical Co., Ltd58