Bioequivalence Studies of Dasatinib 100 Mg Tablets in Healthy Colombian Subjects in Postprandial Condition
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Concentration
研究概览
简要总结
A bioequivalence study of Dasatinib will be carried out in 46 healthy subjects, in fed condition, following the complete replicated design, randomized, comparative of 2 sequences, 2 study formulations, in a single dose of 100 mg of Dasatinib tablets / coated tablets, 4 periods. , with a washout time of 7 days between each dose
详细描述
A bioequivalence study of Dasatinib in 46 healthy subjects, in fed condition, complete replicated design, comparative of 2 sequences, 2 formulations, single dose of 100 mg of Dasatinib tablets / coated tablets, 4 periods. , with a washout time of 7 days between each dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
randomized
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men of legal age between 18 to 50 years.
- •Have been clinically diagnosed as healthy by the trial doctor.
- •Subjects with clinical laboratory results within normal ranges and/or suitable by medical selection.
- •Non-smoking subjects for the last 3 months.
- •Have signed the informed consent.
- •Body mass index between 18-30 kg/m2
- •Subject with complete contact information (cell phone and/or contact landline, address, email).
- •Subject who has a family member or guardian with a contact telephone number.
- •Subject to the availability of time to comply with scheduled visits and activities.
排除标准
- •Subject with a diagnosis of renal, cardiac, hepatic, immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric disease.
- •Subjects diagnosed with positive COVID 19
- •Subject diagnosed with hematological disorders, such as anemia and/or polycythemia.
- •Subjects with a history of gastric surgeries.
- •Permanent or temporary use during the last 15 days of any type of medication, both on their own initiative and by medical prescription. Except female patients who are planning regularly with the same contraceptive method in the last 6 months prior to the start of this trial.
- •Smoker in the last 3 months, regardless of the number of cigarettes.
- •Consumption of xanthines from coffee, tea or chocolate during the previous 48 hours
- •Drinker of alcohol in more than 16 grams every week equivalent to 1 beer or 2 glasses of wine during the last 15 days.
- •Consumption of drugs of abuse or psychoactive substances reported as a positive test.
- •Known hypersensitivity to the active substance or to the excipients of the test product.
- •Medical history of angioedema or anaphylaxis.
- •Subject diagnosed with human immunodeficiency virus infection, hepatitis B or positive hepatitis C.
- •Have participated in clinical studies in the 4 months prior to the start of this trial.
- •Have donated blood in the 30 days prior to the start of the trial.
研究组 & 干预措施
Liteda®
Dasatinib 100 mg tablets Lab. Tecnofarma Colombia S.A.S. Liteda®
干预措施: Dasatinib 100 MG (Drug)
Sprycel®
Dasatinib 100 mg tablets Lab. Bristol-Myer Squibb Sprycel®
干预措施: Dasatinib 100 MG (Drug)
结局指标
主要结局
Cmax - Maximum Observed Concentration
时间窗: 2 days
Bioequivalence based on Cmax
AUC0-24 - Area Under the Concentration-time Curve From Time Zero to 24 Hours Post-dose
时间窗: 2 days
Bioequivalence based on AUC0-24
次要结局
未报告次要终点
研究者
Humberto Reynales MD MSc PhD
Dr MD MSc PhD
Centro de Atencion e Investigacion Medica