2024-517043-32-00招募中4 期
(IPCOM) Influence of Proton pump inhibitor CO-medication on the absorption of innovator and generic formulations of Mycophenolate mofetil
Leids Universitair Medisch Centrum (LUMC)1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年2月28日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- As primary endpoint the C-max and the area under the concentration-time curve (AUC)(0-12) of MPA will be calculated. Comparisons will be made between the three formulations in AUC according to the criteria for demonstrating bio-equivalence.
研究概览
简要总结
Primary Objectives are 1) To determine the influence of PPI co-treatment on the pharmacokinetics of different formulations of MMF (generic and innovator); 2) To compare the bio-equivalence between innovator MMF and generic formulations of MMF, in subjects co-treated with PPI.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Healthy volunteers (male) as determined by medical history, clinical laboratory tests and physical examination. • ≥ 18 and ≤ 55 years of age • Body weight > 50 kg and Body Mass Index (BMI) between 18.5 and 30 kg/m2 • Vital signs (systolic blood pressure 90–149 mmHg, diastolic blood pressure 50–89 mmHg, heart rate 50–90 bpm, measured after 5 min at rest in the sitting position) • Clinical laboratory test (biochemistry and haematology blood tests and urinalysis) results within normal reference range for the investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. • The ability to fully comprehend the nature and aims of the study, including possible risks and side effects. • Written informed consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study: • Hypersensitivity to the active substance and/or any of the excipients of the formulations or a history of anaphylaxis to drugs or allergic reactions in general. • Moderate or severe hepatic impairment (Child-Pugh A, B or C) • Moderate or severe renal impairment (eGFR below 60 mL/min) • History or presence of clinically significant disease • Clinically significant abnormal physical findings • Clinically significant abnormal laboratory values indicative of physical illness (including hepatic and renal panels, complete blood count). • Participation in the evaluation of any investigational product or donation of blood for 3 months before this study • History of alcohol or drug abuse within the last year • Use of prescription medications within 14 days of study drug administration or over-the-counter (OTC) medications, herbal supplements, or multivitamins within 7 days, with the exception of paracetamol (up to 4 gram/day).
结局指标
主要结局
As primary endpoint the C-max and the area under the concentration-time curve (AUC)(0-12) of MPA will be calculated. Comparisons will be made between the three formulations in AUC according to the criteria for demonstrating bio-equivalence.
As primary endpoint the C-max and the area under the concentration-time curve (AUC)(0-12) of MPA will be calculated. Comparisons will be made between the three formulations in AUC according to the criteria for demonstrating bio-equivalence.
次要结局
未报告次要终点
研究者
Kim Gombert-Handoko
Scientific
Leids Universitair Medisch Centrum (LUMC)
研究点 (1)
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