NCT02902523已完成1 期
Clinical Trial to Assess the Safety and Pharmacokinetics of HUG116 Tablet and Viread® Tablet in Healthy Male 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
- 50
- 试验地点
- 1
- 主要终点
- Area Under Curve(AUC)last of Tenofovir
研究概览
简要总结
A randomized, open-label, single-dosing, 2x2 crossover study to compare the safety and pharmacokinetics of HUG116 tablet(Tenofovir Disoproxil) with Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 19 to 45, healthy male subjects(at screening)
- •Body weight over 55kg, in the range of calculated Ideal Body Weight ± 20%
- •Subject without a hereditary problems, chronic disease and morbid symptom
- •Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
排除标准
- •Volunteer who has past or present history of any diseases following below.(liver, kidney,digestive system, pulmonary,hematooncology, endocrine, urinary,neurology,mental disorder, skeletomuscular, immunology, otolaryngology,cardiovascular)
- •Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
- •Volunteer who had hypersensitivity reaction to medicines including Tenofovir
- •Volunteer who has genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance
- •Sitting systolic blood pressure > 140mmHg or < 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or < 60mmHg, pulse ≥ 100 beats per minute
- •Exceed 2 times the normal range of AST, ALT, Total Bilirubin at screening test
- •Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable)
- •Have the result of serum test(RPR Ab(VDRL), HBsAg, HCV Ab, Anti HIV(AIDS)) is a positive
- •History of drug abuse, or a positive urine drug screen
- •Having ETC drug or herbal medicines within 2 weeks before first administration or OTC drug or vitamin preparations within a week before first administration
- •Participation in any other clinical trial involving investigational drugs within 3 months
- •Volunteer who had whole blood donation in 2 months, or component blood donation or transfusion in 1 months
- •Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
- •Volunteers smoking over 10 cigarettes per day in the last 3 months and taking a surfeit of caffeine(caffeine>400mg per day)
- •Subjects with planning of dental treatment (tooth extraction, endodontic treatment etc.) and any surgery (aesthetic operation, laser in-situ keratomileusis, laser assisted sub-epithelial keratomileusis etc.) from signed on an informed consent form to post-study visit
- •Any condition that, in the view of the investigator, would interfere with study participation
研究组 & 干预措施
Viread ® tablet 300mg
Active Comparator
Tenofovir disoproxil fumarate
干预措施: Viread® tablet 300mg (Drug)
HUG116 tablet 245mg
Experimental
Tenofovir disoproxil
干预措施: HUG116 tablet 245mg (Drug)
结局指标
主要结局
Area Under Curve(AUC)last of Tenofovir
时间窗: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
Maximum of concentration(Cmax) of Tenofovir
时间窗: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
次要结局
- t1/2β of Tenofovir(0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h)
- Clearance/F of Tenofovir(0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h)
- Area Under Curve(AUC)inf of Tenofovir(0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h)
- tmax of Tenofovir(0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir Disoproxil Fumarate) in Healthy Male VolunteersHepatitisNCT02920931Boryung Pharmaceutical Co., Ltd50
已完成
1 期
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/RosuvastatinHypertensionHyperlipidemiaNCT02569814Boryung Pharmaceutical Co., Ltd100
已完成
1 期
A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of UI15AML055MT and Amosartan® Tablet 5/50 mg After a Single Oral Administration in Healthy Male VolunteersHealthyNCT02166398Korea United Pharm. Inc.46
已完成
1 期
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy SubjectsHepatitis BNCT04906109Dong-A ST Co., Ltd.96
已完成
1 期
A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination With Coadministration of Cilnidipine and ValsartanHypertensionNCT02343250IlDong Pharmaceutical Co Ltd54