NCT04486157已完成1 期
A Phase 1, Open Label, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Crossover Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects
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
- 44
- 试验地点
- 1
- 主要终点
- AUC0-t of netupitant
研究概览
简要总结
The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation
详细描述
[Pharmacokinetics Assessment]
- Primary Parameter
- AUC0-t
- Secondary Parameters - Cmax, tmax
[Safety Assessment]
- Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged between 19-45
- •Body weight ≥ 50kg and in the range of ideal body weight ± 20%
- •Without congenital, or chronic diseases within recent 5 years
- •Subjects who are deemed eligible based on the screening tests
- •Subjects who received a full explanation of the study, understood the purpose and details of this study, characteristics of the investigational product, and expected adverse events, and voluntarily signed the informed consent form
- •Agree to use acceptable contraceptive methods from signing the informed consent to 3 weeks after the last dose of the investigational product
- •Able and willing to comply with study requirements including all scheduled inpatient and outpatient visits, clinical laboratory tests, and instructions.
排除标准
- •A subject with symptoms suspected of acute illness at the screening
- •A subject with clinically significant and active cardiovascular, respiratory, kidney, endocrine, hematological, gastrointestinal, central nervous system diseases, psychiatric disorders, or malignant tumors
- •A history of gastrointestinal disease
- •Known hypersensitivity to the active ingredient or excipients of investigational product or a history of clinically significant hypersensitivity
- •A history of drug abuse
- •Pregnant women or women who may be pregnant, and breastfeeding women
- •Subjects who are deemed inappropriate to participate in the study by the investigator for other reasons
研究组 & 干预措施
IN-A012
Experimental
Intravenous administration of IN-A012
干预措施: IN-A012 (Drug)
Akynzeo capsules
Active Comparator
Single oral administration of Akynzeo capsules
干预措施: Akynzeo 300Mg-0.5Mg Capsule (Drug)
结局指标
主要结局
AUC0-t of netupitant
时间窗: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose
Area under the plasma concentration versus time curve of netupitant
次要结局
- Cmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron(pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose)
- tmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron(pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Study to Evaluate Multiple Doses in Patients With Nasal PolyposisNasal PolyposisNCT02734849Allakos Inc.40
已完成
1 期
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy ParticipantsHealthy SubjectsNCT04096157Astellas Pharma Global Development, Inc.17
终止
2 期
A Phase II Study of ACZONE™ (Dapsone) Gel, 5% As a Treatment For Tarceva® (Erlotinib)Related RashRashNon-small-Cell Lung CancerNCT00343187Allergan2
已完成
1 期
A Study of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic ConjunctivitisAtopic KeratoconjunctivitisVernal KeratoconjunctivitisPerennial Allergic ConjunctivitisNCT03379311Allakos Inc.30
已完成
1 期
A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, for Advanced Solid Tumors or With mXELOX/XELOX as First-line Therapy for Advanced Gastric or GEJ AdenocarcinomaGastric AdenocarcinomaAdvanced Solid TumorsGastroesophageal Junction AdenocarcinomaNCT03852251Akeso338