KCT0007258招募中未知
A phase 1 clinical trial to evaluate the safety and pharmacokinetic characteristics after administration of fixed-dose combination of NGL-101 and loose-combination of each component in healthy adult volunteers
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 40
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) Healthy adult volunteers over the age of 19 at screening
- •2) Those who weigh more than 50.0 kg and have a body mass index (BMI) of 18.0 kg/m2 or more than 30.0 kg/m2
- •3) Those who do not have a congenital or chronic disease requiring treatment and who do not have any pathological symptoms or findings as a result of medical examination
- •4) Those who have been determined to be suitable as a clinical trial subject as a result of clinical laboratory tests and vital signs, physical examination (physical examination), and 12-lead electrocardiogram that are set and conducted according to the characteristics of the drug for clinical trial at screening
- •5) After explanation and fully understanding the detailed description of this trial, the person who has voluntarily decided to participate and has agreed in writing to comply with the subject precautions during the trial
排除标准
- •1) Persons with a current or history of clinically significant liver, kidney, nervous system, psychiatric system, respiratory system, endocrine system, blood disease, tumor, genitourinary system, cardiovascular, digestive system, musculoskeletal system, etc., in addition to those with the following or histories:
- •? Patients with type 1 diabetes or diabetic ketoacidosis
- •? Patients with acute kidney injury and renal dysfunction
- •? Patients with hepatic impairment
- •? Patients receiving insulin secretion promoters or diuretics such as insulin and sulfonylurea
- •? Patients at risk of decreased fluid volume and/or hypotension
- •? Patients with bladder underlying disease
- •? Urinary sepsis and pyelonephritis
- •? Genital infections (including fungi)
- •2) Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •3) Those who have a history of gastrointestinal diseases (such as Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgeries (except simple appendectomy or hernia surgery) that may affect the absorption of investigational product.
- •4) Pregnant women (Urine HCG positive) or lactating women
- •5) Those with a history of hypersensitivity reactions (anaphylactic or angioedema, etc.) or clinically significant hypersensitivity to Dapagliflozin, drugs including Sitagliptin components, formulation additives and other drugs (aspirin, penicillin-based antibiotics, macrolide-based antibiotics, etc.)
- •6) At screening, those who have clinically significant findings, including the following findings on a 12-lead electrocardiogram
- •?QTc > 450 ms
- •?PR interval > 200 ms
- •?QRS duration > 120 ms
- •7) At screening, the person who shows the following results in the clinical laboratory test
- •? Those whose AST, ALT, ALP, ?-GTP and Bilirubin total in clinical laboratory tests for the evaluation of liver function exceed 2 times the upper limit of the normal range
- •? Creatinine levels in the blood are outside the reference range, or the eGFR calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula is less than 60 mL/min/1.73 m2.
- •8) History of substance abuse or have tested positive for an abused drug on a urine drug test.
- •9) At screening, those who showed systolic blood pressure = 150 mmHg or = 90 mmHg or diastolic blood pressure = 100 mmHg or = 60 mmHg, pulse = 40 bpm or = 100 bpm on vital signs measured from the left after a break of at least 3 minutes
- •10) Abnormal diets that may affect the absorption, distribution, metabolism and excretion of investigational product, or those who consume foods that may affect drug metabolism
- •11) Those who have been administered any specialty or herbal medicine that may affect the properties of the investigational product, including cyclosporin, rifampicin and mephenamic acid, within 2 weeks prior to the first day of administration, or who have received any over-the-counter drug (OTC drug) or vitamin preparation within 10 days.
- •12) Those who have administered drug metabolic enzyme induction and inhibition drugs such as barbiturates drugs within 1 month before the first day of administration
- •13) Those who have participated in other clinical trials or bioequivalence trials and received administration within 6 months prior to the date of first administration
- •14) Those who donate whole blood within 2 months prior to the date of first dose, or who have donated ingredients within 1 month, who have received a
研究者
相似试验
已完成
不适用
Comparison of pharmacokinetics between administration of fixed-dose combination or loose combination of HUG186(Bazedoxifene and Cholecalciferol)KCT0003839Huons52
已完成
1 期
A Phase I clinical trial to evaluate the safety and pharmacokinetics of SHR0302 base ointment at single dose and multiple dose in healthy adult subjectsAtopic dermatitisSkin - Dermatological conditionsACTRN12619001443189Reistone Biopharma Co., Ltd.32
进行中（未招募）
1 期
A dendritic cell vaccine to suppress the immune response to citrullinated antigen in rheumatoid arthritisRheumatoid arthritisACTRN12610000373077niquest18
进行中（未招募）
1 期
A Phase I clinical trial to assess the safety and immunogenicity of HIV DNA immunisations administered via the Intramuscular and Intradermal methods with and without electroporation followed by boosting with recombinant HIV protein in healthy male and female volunteersHIV prophylaxisMedDRA version: 18.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestationsEUCTR2015-001023-23-GBImperial College London28
已完成
1 期
A first-in-human safety study of the novel adrenal PET tracer [18F]CETOPrimary aldosteronismNutritional, Metabolic, EndocrinePrimary hyperaldosteronismISRCTN16159564Cambridge University Hospitals NHS Foundation Trust11