TCTR20201224002尚未招募1 期
Single-Dose, Fed Bioequivalence Study of MYLAN Rivaroxaban Tablets 20 mg (20 mg;Mylan) and Xarelto® 20 mg (20 mg; Bayer) in Healthy Adult Volunteers
International Bio Service Co.,Ltd.0 个研究点目标入组 36 人开始时间: 2020年12月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 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
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1.Healthy Thai male or female subjects between the ages of 18 to 55 years. Subject
- •must meet age requirements at the time of signing the initial informed consent and
- •at the dosing day in Period 1.
- •2.Body mass index between 18.0 to 30.0 kg/m2
- •3.Normal laboratory values, including vital signs and physical examination, for all
- •parameters in clinical laboratory tests at screening.
- •Any abnormalities from the normal or reference range will be carefully
- •considered clinically relevant by the physician as individual cases, documented
- •in study files prior to enrolling the subject in this study.
- •4.Non-smoker and non-consumer of nicotine containing products
- •Non-smoker or non-consumer of nicotine containing products means any
- •subject who has never smoked or stopped for at least 90 days.
- •5.Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
- •6.Female subjects abstain from either hormonal methods of contraception (including
- •oral or transdermal contraceptives, injectable progesterone, progestin subdermal
- •implants, progesterone-releasing IUDs, postcoital contraceptive methods) or
- •hormone replacement therapy for at least 28 days prior to check-in in Period 1.
- •injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6
- •months prior to check-in in Period 1. Subjects agree to use acceptable nonhormonal contraceptive methods such as condom, diaphragm, foams, jellies, or
- •abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the
- •end of study in Period 2. Female subjects of non-childbearing potential must meet
- •at least one of the following criteria prior to check-in in Period 1:
- •ï‚· Postmenopausal for at least 1 year or
- •ï‚· Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or
- •hysterectomy) at least 6 months
- •7.Male subjects who are willing or able to use effective contraceptive e.g. condom or
- •abstinence after check-in in Period 1 until 7 days after the end of study in Period 2.
- •8.Able to understand and voluntarily given written informed consent (signed and
- •dated) by the subject prior to participating in this study.
- •9.Adequate venous access in both arms for the collection of a number of samples
- •during the study
排除标准
- •1.History of allergic reaction or hypersensitivity to rivaroxaban or to any excipients
- •2.History or evidence of clinically significant renal, hepatic, gastrointestinal,
- •hematological (e.g. anemia), endocrine (e.g. hyper-/hypothyroid, diabetes),
- •pulmonary or respiratory (e.g. asthma), cardiovascular, psychiatric (e.g.
- •depression), neurologic (e.g. convulsant), allergic disease (including drug allergies,
- •but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any
- •significant ongoing chronic medical illness
- •3.Have high risk for coronavirus infection based on risk assessment questionnaire or
- •diagnosed as confirmed case of COVID-19
- •4.History or evidence of coagulation disorders e.g. von Willebrand's disease,
- •5.Active clinically significant bleeding e.g. intracranial or intracerebral bleeding,
- •gastrointestinal bleeding
- •6.History or evidence of disorders with increased bleeding risk e.g. periodontosis,
- •hemorrhoids, recent gastrointestinal bleeding or ulceration such as acute gastritis,
- •peptic ulcer, inflammatory bowel disease, gastroesophageal reflux disease, presence
- •of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent
- •brain, spinal or ophthalmic surgery, oesophageal varices, oesophagitis,
- •arteriovenous malformations, vascular aneurysms, vascular retinopathy or major
- •intraspinal or intracerebral vascular abnormalities, bronchiectasis or history of
- •pulmonary bleeding.
- •7.History or evidence of galactose intolerance, the Lapp lactase deficiency or
- •glucose-galactose malabsorption
- •8.History of sensitivity to heparin or heparin-induced thrombocytopenia
- •9.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy,
- •gastritis or duodenal or gastric ulceration other than appendectomy
- •10.History of preceding diarrhea within 24 hours prior to check-in in each period
- •11.History of febrile illness within 7 days prior to check-in in each period
- •12.History of problems with swallowing tablet or capsule
- •13.History or evidence of drug addict or investigation with urine sample shows a
- •positive test for drug of abuse (morphine, marijuana or methamphetamine)
- •14.Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg
- •and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on
- •screening day and check-in day. If abnormal blood pressure detects, the
- •measurement should be repeated two more times after take a rest for at least 5 mins
- •each. The last measurement value should be used to determine the subject‟s
- •eligibility.
- •15.12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an
- •abnormality considered clinically significant at screening. If QTc exceeds 450
- •msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the
- •average of the three QTc or QRS values will be used to determine the subject‟s
- •eligibility.
- •16.Investigation with blood sample shows positive test for HBsAg.
- •17.Abnormal liver function, ≥1.5 times of upper normal limit of reference range for
- •ALT, AST or bilirubin levels at screening laboratory test
- •18.Have renal creatinine clearance (Clcr) <50 mL/min based on serum creatinine
- •results, using glomerular filtration rate (GFR; Cockcroft-G
研究者
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