KCT0003988已完成未知
A randomized, double-blind, placebo-controlled single and multiple dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 gel after transdermal administration in healthy male volunteers
Shaperon0 个研究点目标入组 56 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
- 56
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
- 20(Year) 至 50(Year)（—）
- 性别
- Male
入选标准
- •Selection Criteria
- •1) Heathy male aged from 20 to 50 at screening test
- •2) Weight minimum 45kg, maximum 90kg with BMI minimum 17kg/m2 maximum 27.0 kg/m2
- •? BMI (kg/m2) = weight (kg) / {height (m)}2
- •3) No skin diseases, no skin damages(scars, tattoo, etc), no hairy skin in drug-applied area which may cause the alteration of drug absorbtion
- •4) volunteer with full knowledge of details on the clinical tirals and written consent to observe requirements
排除标准
- •Exclusion Criteria
- •1) Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs containing Taurodeoxycholateor generic drugs (aspirin, antibiotics, etc.)
- •2) Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic diseases, mental diseases, especially hemorrhagic diseases (hemophilia, von Willebrand disease, etc.), cardiovascular diseases (coronary artery disease, Congestive heart failure, arrhythmia, cerebrovascular disease, etc.) or who have a history of those diseases
- •3) Those who had clinical symptoms suspected of acute infectious disease within 2 weeks before the scheduled date of the first administration, or whose temperature measured by the screening test (eardrum) was 38.0 ° C or higher
- •4) Those who have taken any ETC medicines, herbal medicines, crude drugs within 2 weeks before the scheduled date of administration of the medicines for clinical trials , or OTC medicines or vitamin preparations within 1 week (if all other selection / exclusion criteria are met , The researcher should consult with the sponsor to determine whether it is appropriate to take the subject into the trials, considering the safety of the subject or the effect on overall clinical trial results.)
- •5) Those who have a history of substance abuse, or positive urine screening tests (cannabinoid, opiates, amphetamine, cocaine, barbiturate, benzodiazepine)
- •6) Those who have a history of smoking within 3 months (However, if they quit smoking three months before the first scheduled medication, they are eligible for selection)
- •7) Those who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody)
- •8) Those who drink continuously (above 21 units / week, 1 unit = 10 g of pure alcohol)
- •9) Those who have been taking medicines by participating in other clinical trials or bioequivalence studies within 3 months prior to the date of first dosing (the time from the date of the previous clinical trial will be based on the date of administration of each relevant clinical trial drug, If the half-life of a test drug taken in a clinical trial is more than two weeks, it may be attained more than five times the expected half-life of the test drug.)
- •10) Those who have been bleeding, blood drawings or blood donation of 400mL or more within 8 weeks before the scheduled date of administration of the drug for clinical trials
- •11) Those who have vital signs measured at sitting postion after the break for more than 3 minutes,
- •? Low blood pressure (systolic blood pressure <90 mmHg, diastolic blood pressure <50 mmHg)
- •? High blood pressure (systolic blood pressure greater than 150 mmHg, diastolic blood pressure greater than 100 mmHg)
- •12) Test subjects who are deemed unsuitable for participating in clinical trials due to clinical laboratory tests, ECG results, or other reasons
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