NL-OMON47715已完成不适用
Biocomparison study of crushed elbasvir/grazoprevir compared to the whole tablet (CRUSADE-2)/Hep-NED005 - CRUSADE-2
Afdeling Apotheek0 个研究点目标入组 11 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Subject is at least 18 and not older than 55 years at screening.
- •2. Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to Day 1.
- •3. Subject weighs at least 40 kg.
- •4. Subject has a Quetelet Index (Body Mass Index) of 18 to 35 kg/m2, extremes included.
- •5. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- •6. Subject is in good age-appropriate health condition as established by medical history, physical examination, and electrocardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to Day 1. Results of biochemistry, haematology and urinalysis testing should be within the laboratory's reference ranges. If laboratory results are not within the reference ranges, the subject is included on condition that the Investigator judges that the deviations are not clinically relevant. This should be clearly recorded.
- •7. Subject has a normal blood pressure and pulse rate, according to the Investigator's judgment.
排除标准
- •1. Creatinine clearance below 60 mL/min.
- •2. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- •3. Positive hepatitis B or C test
- •4. Pregnant female (as confirmed by an hCG test performed less than 4 weeks before day 1) or breast-feeding female. Female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout the entire conduct of the study.
- •5. Therapy with any drug (for two weeks preceding Day 1), except for acetaminophen (max 2 gram/day), intrauterine device.
- •6. Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures), psychiatric disorders, gastro-intestinal disorders, renal and hepatic disorders (clinically relevant increased ALAT/ASAT or hyperbilirubinemia), hormonal disorders (especially diabetes mellitus), coagulation disorders.
- •7. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- •8. History of or current abuse of drugs, alcohol or solvents (positive drugs of abuse test).
- •9. Inability to understand the nature and extent of the study and the procedures required.
- •10. Participation in a drug study within 60 days prior to Day 1.
- •11. Donation of blood within 60 days prior to Day 1.
- •12. Febrile illness within 3 days before Day 1.
- •13. Co-worker of Radboud university medical center.
研究者
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