NCT06834451进行中（未招募）4 期
Bioequivalence Study of Revolade® Eltrombopag 50 mg Tablets - Novartis Vs Myelone ® Eltrombopag 50 mg Tablets - Colompack / Immediate Release Tablets in Healthy Subjects Under Fasting Condition
Centro de Atencion e Investigacion Medica1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Outcome Measures
研究概览
简要总结
Bioequivalence Study
详细描述
A bioequivalence study of Eltrombopag will be developed in 30 healthy subjects, under fasting condition, following the design:
Open-label, crossover, randomized, single-dose design of 50 mg Eltrombopag tablets/immediate release tablets, with two treatments, two periods, two sequences in healthy volunteers in fasting condition, with a washout time of 15 days between each dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men between 18 and 50 years of age. Have been clinically diagnosed as healthy by the trial physician. Subjects with clinical laboratory results requested in the protocol (Table 2) within normal ranges and/or fit by medical screening. Current for 3 months.
- •Subjects non-smokers for the last 3 months. Having signed the informed consent. Subjects sexually active or of reproductive age must use an effective contraceptive method during and for at least 7 days after the end of the study.
- •Body mass index between 18-30 kg/m2 at the time of inclusion in the study. Subject with complete contact information (cell phone and/or landline contact, address, email).
- •Subject who has a family member or guardian with a contact telephone number. Subject with the availability of time to comply with the scheduled visits and activities.
排除标准
- •Subject with a diagnosis of renal, cardiac, hepatic, immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric disease.
- •Woman in a state of pregnancy or breastfeeding. Subject diagnosed with hematological disorders, such as anemias and/or polycythemia.
- •Subjects with a history of gastric surgeries. Permanent or temporary use during the last 15 days of any type of medication either on their own initiative or 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 the present trial.
- •Consumption of xanthines from coffee, tea or chocolate during the 48 hours prior to hospitalization.
- •Drinking alcohol in excess of 16 grams every week equivalent to 1 beer or 2 glasses of wine during the last 15 days prior to hospitalization.
- •Consumption of drugs of abuse or psychoactive substances reported as positive test at the time of hospitalization.
- •Known hypersensitivity to the active ingredient or excipients of the test product.
- •Medical history of angioedema or anaphylaxis. Subject diagnosed with human immunodeficiency virus infection, hepatitis B or hepatitis C positive.
- •Having participated in clinical studies in the 4 months prior to the time of signing the informed consent.
- •Having donated blood in the 30 days prior to the time of signing the informed consent.
研究组 & 干预措施
Period 2
Active Comparator
Eltrombopag TEST
干预措施: Eltrombopag (EPAG) (Drug)
Period 1
Active Comparator
Revolade® Reference
干预措施: Eltrombopag (EPAG) (Drug)
Period 2
Active Comparator
Eltrombopag TEST
干预措施: Revolade® (Drug)
Period 1
Active Comparator
Revolade® Reference
干预措施: Revolade® (Drug)
结局指标
主要结局
Pharmacokinetic Outcome Measures
时间窗: 0 - 6 hours
Area under the plasma concentration versus time curve (AUC)
次要结局
未报告次要终点
研究者
Humberto Reynales MD MSc PhD
Principla Investigator
Centro de Atencion e Investigacion Medica
研究点 (1)
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