KCT0003839已完成未知
A phase 1 clinical trial to evaluate the safety and pharmacokinetic characteristics after administration of fixed-dose combination or loose combination of HUG186 in healthy adult male or menopausal female volunteers
Huons0 个研究点目标入组 52 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Men who are healthy adults aged 19 years or over at the time of screening or women who are over 35 years old and whose menopausal symptoms have been proven through gynecological examination
- •- 12 months after the final menstrual period
- •- Volunteers whose serum FSH (follicle stimulating hormone) is above the menopausal level
- •2) Those with a body weight of 50.0 kg or more and a body mass index (BMI) of 18.5 kg / m2 to 30.0 kg / m2
- •* BMI = body weight (kg) / {height (m)} 2
- •3) Patients without congenital or chronic diseases requiring medical treatment and no medical symptoms or symptoms
- •4) Clinical laboratory tests and vital signs such as serum test, hematology test, blood chemistry test, blood coagulation test, urine test, urine drug test, and 12-lead electrocardiogram test were performed according to the characteristics of the drug during the screening test. A person determined to be suitable for
- •5) Those who agree to apply sunscreen when exposed to sunlight for more than 1 hour.
- •6) Other foods with high vitamin content, including vitamin D, foods with enhanced vitamin content, and those who have agreed to prohibit consumption of vitamin D supplements
- •7) Having heard and fully understood the details of this clinical trial and agreed in writing to voluntarily participate in the study and agreed to keep the subject compliance during the clinical trial
排除标准
- •1) A volunteer with clinically significant liver, kidney, nervous system, respiratory, digestive, endocrine, hematologic, urographic, cardiovascular, musculoskeletal or mental illnesses,
- •? venous thromboembolism (deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, etc.)
- •? Patients with hypertriglyceridemia
- •? Patients with renal disease, patients with renal stone, patients with renal failure
- •? Patients with liver disorder
- •? hypercalcium patients, sarcoidosis
- •? and calcium urine patients
- •? patients with unexplained uterine bleeding
- •? Patients with symptoms or signs of endometrial cancer
- •? People with vitamin D deficiency
- •2) Those who have a history of hypersensitivity reaction to clinically significant components or constituents of clinical trial medicines or other clinically significant drugs or additives
- •3) Those who show the following results in clinical laboratory tests
- •? Liver function tests AST and ALT exceed 1.5 times the upper limit of normal range
- •If serum creatinine level exceeds the normal range or eGFR calculated by the Modification of Diet in Renal Disease (MDRD) is less than 60 mL / min / 1.73 m2
- •4) Clinical laboratory tests other than those mentioned above exceed the upper limit of the reference range by more than 2 times, and those who show significant abnormalities in the clinical judgment by the researcher
- •5) At the screening, 12-lead electrocardiogram with clinically significant findings including the following findings
- •? QTc> 450 msec
- •? PR interval> 200 msec
- •? QRS duration> 120 msec
- •6) Screening showed a value corresponding to systolic blood pressure = 150 mmHg or =90 mmHg, or diastolic blood pressure = 100 mmHg or = 60 mmHg in the vital sign measured in the sitting position after resting for more than 3 minutes
- •7) A history of drug abuse or a positive urine drug test for abuse
- •8) Drugs for Clinical Trials Drugs that have been known to inhibit drug metabolizing enzymes (eg, barbiturate including phenobarbital) or inhibitors within 30 days of the first dose
- •9) Clinical trial medicines Any specialty medicinal product that may affect the characteristics of the clinical trial medicines, including cyclosporine, within 10 days prior to the first administration (eg, benzothiadiazine derivatives in case of cholecalciferol, UGT enzyme-inducing drugs (rifampin, carbamazepine, phenytoin)), Chinese herbal medicines, OTC medicines, or vitamin supplements within 2 weeks (provided that the medicinal product has a pharmacokinetic profile If there is no effect, you can participate in clinical trials at the discretion of the tester.)
- •10) Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •11) Those who have been prescribed medication within 3 months (12 weeks) of the first administration before participating in other drug clinical trials or bioequivalence studies.
- •12) All blood donations within 2 months before the first administration, blood donation within 1 month, or blood transfusion within 1 month before the first administration
- •13) Drinking continuously (21 units / week, 1 unit = 10 g = 12.5 mL of pure alcohol) within 6 months of the first administration, or one person who can not abstain (250 ml) = 10 g, shochu (20%) 1 glass (50 ml) = 8 g, wine (12%) 1 glass (125 ml) = 12 g)
- •14) Smokers with an average daily smoking amount exceeding 10 per day during the last 3 months, and those who can not quit smoking 48 hours before the last bloo
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