EUCTR2015-001245-89-Outside-EU/EEA进行中（未招募）不适用
Relative bioavailability study between 75 mg tablet and 75 mg solution of Clopidogrel (SR25990C) after single oral administration to young healthy men. Open, crossover, randomized and monocenter study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Male healthy subjects, between 18 and 40 years of age.
- •2. Weight between 60 kg and 90 kg, Body Mass Index between 18 and 28 kg/m2, inclusive (Appendix 1).
- •3. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- •4. Normal vital signs after 10 minutes in supine position:
- •95 mmHg < systolic blood pressure < 140 mmHg,
- •50 mmHg < diastolic blood pressure < 90 mmHg,
- •45 bpm = heart rate = 90 bpm.
- •5. Normal 12-lead ECG, , PR < 210 ms, QRS < 120 ms, QTcB = 430 ms (incomplete bundle branch block can be accepted).
- •6. Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator.
- •7. Having given a written informed consent prior to selection.
- •8. Subject with normal dietary habits.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease.
- •2. Frequent headaches and / or migraine, recurrent nausea and / or vomiting.
- •3. Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position.
- •4. Blood donation (including in the frame of a clinical trial) or general anesthesia within 3 months before administration.
- •5. Presence or history of any allergy or unusual reactions to drugs or anesthetics.
- •6. Unable to abstain from intensive muscular effort.
- •7. Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development.
- •8. Subject in the exclusion period of a previous study.
- •9. Subject who cannot be contacted in case of emergency.
- •10. Any medication within one month before the administration, or within 6 times the elimination half-life of that drug.
- •11. Any drug intake within 3 months before administration which could lead to induction or inhibition of microsomal enzymes (Appendix 5).
- •12. History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day) (Appendix 2).
- •13. Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day).
- •14. Smoking more than 5 cigarettes or equivalent / day.
- •15. Positive HBs antigen or anti HCV antibody, or positive results for HIV tests.
- •16. Positive results of screening for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
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