NCT02631954已完成1 期
Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers
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 of Voriconazole
研究概览
简要总结
Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers
详细描述
To healthy volunteers subjects of twenty four(24), following treatments are administered dosing in each period injected wash-out period is a minimum of 7days. Treatment A(Test Drug): Vorico Injection 200mg(Voriconazole) for Single Dose Treatment B(Reference Drug): Vfend® IV 200mg for Single Dose Pharmacokinetic blood samples are collected up to 24hrs.
Safety and pharmacokinetic are assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A healthy person whose age is in between 19 to 55 during the screening tests
- •Whose weight is more than 55 kg, BMI is over 18.5 and under 30.0 during the screening test. (BMI (kg/m2) = weight (kg) / {height (m)}2)
- •Who is completely informed and understand about this clinical trial, voluntarily participating it, and signed to follow the given instructions
- •Who is proven to fit into the clinical trial following by physical examination, ECG (electrocardiogram), clinical laboratory test, medical examination
- •Who agreed to do birth control during testing
- •A male who did not have vasectomy has to follow the clinically proven contraceptive methods* listed under, and who agreed not to donate sperm during the test
- •* Clinically proven contraceptive method: intrauterine device (ex. Lippes Loop, Minera), chemical contraceptive (spermicides) for use with physical contraceptive method (males or females), contraceptive implants (ex. Implanon), tubal ligation or laparoscopy (common methods of tubal ligation)
- •A woman of childbearing age who agreed on constant use of a medically disproven Dual Protection method** and spermicides except hormonal contraceptive, and who also agreed not to breastfeed.
- •A Dual Protection method: use of condoms, the Intrauterine Contraceptive Device, the diaphragm, the cervical cap, in the case where a sexual partner had vasectomy over 3 months ago (from the date of initial screening) or a sexual partner had been medically diagnosed sterile.
排除标准
- •A person who has a history of clinically significant cardiovascular, respiratory, liver, kidney, endocrine system, immune system, urinary system diseases, blood-tumor diseases, mental illness.
- •Who has a history of hypersensitivity reactions to antifungal drugs including voriconazole or similar series or other excipient ingredients (aspirin, antibiotics, etc.)
- •Who has genetics issues on galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
- •Who has a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (other than simple appendectomy and herniotomy)
- •A person whose electrocardiogram value includes QTc > 440 msec, PR < 110 msec or PR > 200 msec, QRS < 60 msec or QRS > 110 msec after screening, or who show clinically significant opinion.
- •Who falls under the following results
- •AST, ALT are exceeded over 1.5x the upper limit of the normal range
- •Total bilirubin is exceeded over 1.5x the upper limit of the normal range
- •Who shows the vital sign values of more than 140 mmHg or less than 90 mmHg in systolic pressure or more than 100 mmHg or less than 60 mmHg in diastolic blood pressure
- •Who has history of drug abuses or shows a positive result in the urinary drug screen
- •Who took any prescribed drugs, medicinal plants within the 2 weeks before the first day of dosing or takes any over-the-counter drugs or vitamin supplements within 1 week (but, if other conditions are met, they can still participate in the clinical test through the researcher's judgment)
- •Who took other investigational drugs or bioequivalence drugs within 3 months before the first day of dosing
- •Who participated in whole blood donation within 2 months before the first of dosing, or platelet donations within 1 months. Who received blood a month before the first day of dosing
- •Who constantly drinks alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol) or cannot stop drinking alcohol during the clinical test.
- •Who smokes more than 10 cigarettes per day, or who cannot quit smoking when hospitalized
- •Who absorb caffeinated drinks (coffee, tea (black or green tea), soda, coffee flavored milk, energy drinks, etc.) or cannot stop absorbing them 24 hours before hospitalization until discharging
- •Who takes drug metabolism drug like barbital drugs which inhibit or activate the metabolism or drugs, or who takes one of the following drugs: St. John's Wort, rifabutin, rifampicin, carbamazepine, phenobarbital, high-dose of ritonavir, terfenadine, astemizole, cisapride, pimozide, quinidine, sirolimus, ergot, alkaloid (ergotamine, dihydroergotamine), efavirenz
- •Who was having foods (especially grapefruit or products contain grapefruit) that can influence the drug absorption, distribution, metabolism, and excretion within 7 days from the first day of dosage
- •A woman who is pregnant, shows positive result in serum/urine test, or who is breastfeeding
研究组 & 干预措施
TR Group
Experimental
Test drug: Vorico Injection 200mg(Voriconazole) Wash out: 7 days Reference drug: Vfend® IV 200mg
干预措施: Vorico Injection 200mg(Voriconazole) (Drug)
TR Group
Experimental
Test drug: Vorico Injection 200mg(Voriconazole) Wash out: 7 days Reference drug: Vfend® IV 200mg
干预措施: Vfend®(Voriconazole) IV 200mg (Drug)
RT group
Experimental
Reference drug: Vfend® IV 200mg Wash out: 7 days Test drug: Vorico Injection 200mg(Voriconazole)
干预措施: Vorico Injection 200mg(Voriconazole) (Drug)
RT group
Experimental
Reference drug: Vfend® IV 200mg Wash out: 7 days Test drug: Vorico Injection 200mg(Voriconazole)
干预措施: Vfend®(Voriconazole) IV 200mg (Drug)
结局指标
主要结局
Cmax of Voriconazole
时间窗: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
The blood sampleing coleected from the subjects was analyzed and result was obtained.
AUCt of Voriconazole
时间窗: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
The blood sampleing coleected from the subjects was analyzed and result was obtained.
次要结局
- Kel (Elemination Rate Constant)(0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs)
- AUCinf of Voriconazole(0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs)
- AUCt/AUCinf(0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs)
- Tmax of Voriconazole(0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs)
- t1/2(0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs)
研究者
研究点 (1)
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