KCT0001312已完成未知
A randomized, open-label, single dose, parallel study to evaluate the pharmacokinetics dose proportionality of GLA5PR GLARS-NF1 tablet in healthy male volunteers
GL PharmTech0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 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 45(Year)（—）
- 性别
- Male
入选标准
- •(1) 19~ 45 aged healthy adult male
- •(2) Body weight at least 45kg and BMI(body mass index) within the range of 17.5 to 30.5kg/m2
- •(3) Do not have any disease or symptoms which is clinically significant
- •(4) Acceptable physical examination and clinical examination, during screening
- •(5) Provision of signed written informed consent
排除标准
- •(1) Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- •(2) A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- •(3) History of regular alcohol consumption exceeding 210g/week (1 drink (250mL) = 10g of beer (5%), 1 drink (50mL) = 8g of hard liquor (20%), 1 drink (125mL) = 12g of wine (12%)) within 6 months of Screening.
- •(4) Participation in clinical trials of any drug within 60 days prior to the participation of the study
- •(5) Systolic BP =140 mmHg or Diastolic BP =90 mmHg
- •(6) someone who has a history of drug abuse or misuse
- •(7) IP first dose before significant induction or that person taking drugs known to inhibit drug-metabolizing enzymes within 30 days
- •(8) Use of tobacco in excess of the equivalent of 5 cigarettes per day
- •(9) someone who has taken other ETC drugs or OTC drugs within the last 10 days or 5 half lives(whichever is longer)
- •(10) Blood donation during 2 months or apheresis during 1 month before the study
- •(11) Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol
- •(12) someone who can't take a meal derived from this trial
- •(13) someone who has taken abnormal meals like which can affect to drug ADME
- •(14) Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
- •(15) Allergy or intolerance to one of the study medications
- •(16) ????? ???(galactose intolerance), Lapp ?????? ???(Lapp lactose deficiency) someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •(17) Judged to be inappropriate for the study by the investigator after reviewing other reasons
研究者
相似试验
已完成
不适用
A randomized, open-label, single-dose parallel-group trial to determine the pharmacokinetics and safety of GP2017 following a single subcutaneous injection by an autoinjector or by a pre-filled syringe in healthy male subjectsautoimmune diseasesincluding rheumatoid arthritis and psoriasis10003816NL-OMON42002Hexal AG108
进行中（未招募）
不适用
Investigation of the ability of MRI to show changes in the nose after treatment of patients with Vicks® Sinex® Micromist®EUCTR2011-002443-10-GBProcter & Gamble Technical Centres Ltd., UK20
尚未招募
不适用
An Open-label, Parallel, Single-Dose, Clinical Study after administration of WS1313D in Children and Adolescent with Pain to Evaluate Pharmacokinetics (PK) / Pharmacodynamics (PD) and SafetyKCT0004166Woosung Pharma62
进行中（未招募）
1 期
A single center, open label,comparitive study to evaluate the Safety, Tolerability and Immunogenicity of two Formulations (with and without preservative) of 10-valent Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) NUCOVAC® in Healthy AdultsCTRI/2013/05/003711PANACEA BIOTEC LIMITED48
已完成
不适用
Randomized, single-dose, parallel-arm, open-label Phase I trial to compare the pharmacokinetics, safety and tolerability of BI 695501 administered subcutaneously via prefilled syringe or autoinjector10003816Rheumatoid arthritisNL-OMON42895Boehringer Ingelheim80