TCTR20210215001尚未招募1 期
A Single Dose, Randomized, Open-label, One-period Parallel Bioequivalence Study of Generic Leflunomide 20 mg Film-coated Tablets and Reference Product (Arava) in Healthy Thai Male Volunteers under Fasting Conditions
International Bio Service Co.,Ltd.0 个研究点目标入组 44 人开始时间: 2021年2月15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
- 44
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
- Male
入选标准
- •1.Healthy Thai male subjects between the ages of 18 to 55 years.
- •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.Male subjects who are not wishing to be a father of a child during the study or who
- •are willing or able to use effective contraceptive e.g. condom or abstinence after
- •check-in until at least 30 days after investigational product administration.
- •5.Have voluntarily given written informed consent (signed and dated) by the subject
- •prior to participating in this study.
排除标准
- •1.History of allergic reaction or hypersensitivity to leflunomide (especially previous
- •Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme),
- •teriflunomide or any of the excipients in the tablet
- •2.History of allergic reaction or hypersensitivity to cholestyramine
- •3.History or evidence of clinically significant renal, hepatic, gastrointestinal,
- •hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes),
- •pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension),
- •psychiatric, neurologic (e.g. convulsion), allergic disease (including drug allergies,
- •but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any
- •significant ongoing chronic medical illness
- •4.Have high risk for coronavirus infection based on risk assessment questionnaire or
- •diagnosed as confirmed case of COVID-19
- •5.History or evidence of easy bruising or bleeding, recurrent infections, fever,
- •paleness or unusual tiredness
- •6.History or evidence of galactose intolerance, the Lapp lactase deficiency or
- •glucose-galactose malabsorption
- •7.History of problems with swallowing tablet or capsule
- •8.History or evidence of impairment of liver function
- •9.History or evidence of moderate to severe renal insufficiency
- •10.History or evidence of severe hypoproteinaemia or nephrotic syndrome
- •11.Investigation with blood sample shows albumin level less than 3.5 g/dl or more
- •than 5.2 g/dl at screening
- •12.Investigation with blood sample shows total protein level less than 6.6 g/dl or more
- •than 8.7 g/dl at screening
- •13.History or evidence of severe immunodeficiency states
- •14.History or evidence of significantly impaired bone marrow function, significant
- •anaemia, leucopenia or thrombocytopenia
- •15.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
- •eligibility.
- •16.History or evidence of colitis
- •17.History or evidence of peripheral neuropathy
- •18.History of sensitivity to heparin or heparin-induced thrombocytopenia
- •19.Any condition possibly affecting drug absorption e.g. oral mucous membrane
- •lesions, gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other
- •than appendectomy
- •20.History of dehydration from diarrhea, vomiting, excess sweating or any other
- •reason within 24 hours prior to check-in or prior to dosing
- •21.History or evidence of drug addict or investigation with urine sample shows a
- •positive test for drug of abuse (morphine, marijuana or methamphetamine)
- •22.12-lead ECG demonstrating QTc >450 , a QRS interval >120 or with an
- •abnormality considered clinically significant at screening. If QTc exceeds 450
- •, or QRS exceeds 120 , 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
- •eligibility.
- •23.Investigation with blood sample shows positive test for HBsAg
- •24.Abnormal liver function, more than 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
- 另有 2 项未显示
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