ISRCTN12520248已完成未知
Pharmacokinetic and pharmacodynamic study of a single dose of rivaroxaban under fed conditions in healthy obese vs non-obese subjects
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 36
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
- 性别
- Male
入选标准
- •1. Healthy participants from the Egyptian general population
- •2. Age 18-60 years
- •3. Body mass index 18.5 – 24.9 kg/m² for normal-weight participants OR BMI = 35 kg/m² for obese participants
- •4. The participant is fully aware of the study details and gave written informed consent
- •5. The physical examination is assessed and accepted by the attending physician
- •6. Oral body temperature within the normal range (35.9 – 37.6°C)
- •7. All laboratory screening results within the normal range for normal-weight volunteers and with some variation from the normal range for the obese participants
- •8. Normal coagulation tests at baseline of the study, i.e., international normalised ratio (INR) up to 1.1, prothrombin time (PT) 10 – 13 seconds, and activated partial thromboplastin time (aPTT) 30 – 40 seconds
排除标准
- •1. History of hypersensitivity to the drug or similar compound
- •2. Having any known coagulation conditions (i.e., von Willebrand disease, haemophilia)
- •3. Having any known increased bleeding risk (i.e., haemorrhoids, peptic ulcer, or frequent nasal bleeding)
- •4. Having any chronic disease/condition (such as diabetes type 2, cardiovascular disease, hypertension, and cancer)
- •5. Known history or presence of food allergies or intolerability (e.g dairy product or gluten-containing food) or any condition is known to interfere with the absorption, distribution, metabolism or excretion of drugs
- •6. Vegetarian
- •7. Exhausting physical exercise in the last 24 hours (e.g. weight lifting).
- •8. History of serious illness that can impact the fate of drugs or clinically significant illness 3 weeks before the study
- •9. Obvious signs of serious renal, gastrointestinal, cardiovascular, hepatic, neurological, musculoskeletal, endocrine disorders as evidenced by physical
- •examination, and/or clinical laboratory tests
- •10. Participant HBsAg, HCV, and HIV positive
- •11. History of drug or alcohol abuse, smoking more than 10 cigarettes or equivalent per day
- •12. Regular use of medication
- •13. Use of any known enzyme inducers or inhibitors (e.g. barbiturates, rivaroxaban, phenytoin, rifampin) within 30 days prior to study entry.
- •14. Use of any prescription or non-prescription (OTC) medication within 3 weeks prior to the study
- •15. Donation of at least 400 ml of blood within 60 days, or more than 150 ml of blood within 30 days, or more than 100 ml blood plasma or platelets within 14 days before the study
- •16. Participation in another study within 60 days prior to the start of this study
- •17. Body mass index less than 18.5 kg/m²
- •18. Hemoglobin Hb less than 13 g/dl
研究者
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