KCT0003368已完成未知
Randomized, open-label, single-dose, three-treatment, three-period, six-sequence, cross-over design phase 1 clinical trial to compare the pharmacokinetics and safety/tolerability after oral administration of Mytonin Tab. 25mg and IY-HCR17 in healthy volunteers
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 36
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
- All
入选标准
- •1) 19~45 yrs old, healthy subjects at screening
- •2) Subjects who are confirmed as non-pregnant in female at screening
- •3) Body mass index(BMI) 18~30(BMI Calculation: weight(kg)/height(m2))
- •4) Those who signed and dated the Informed Consent Form(ICF) voluntarily after fully understanding the ICF <Appendix 3> of this clinical trial.
- •5) Subjects who are willing to follow all planned hospitalization and outpatient visits, administration, laboratory tests and subject compliances.
- •6) Those who are judged by Institution Principal Investigator(or delegated Sub-Investigator) to be suitable as subjects for results of the laboratory tests such as Hematology, Blood chemistry, Urinalysis etc.)
排除标准
- •1) Subjects who have mechanic gastrointestinal tract or urinary tract, spastic gastrointestinal disorders, gastric ulcer, acute gastrointestinal tract inflammatory disease, peritonitis or history of peritonitis, bradycardia or atrioventricular conduction disturbance
- •2) Subjects who have taken drugs within a month prior to screening, which are inducing(ex: Barbiturate) or deducing drug metabolite enzymes
- •3) Subjects who have taken drugs within 10 days prior to screening, which could affect this trial.
- •4) Subjects who have participated in other clinical trials and taken drugs or have participated in bioequivalence trial and taken drugs within 3 months prior to the first administration of investigational product
- •5) Subjects who have given whole blood donation within 2 months or blood component donation within a month prior to the first scheduled administration of investigational product, or have received transfusion within a month prior to the first scheduled administration of investigational product
- •6) Subject who is unable to perform pharmacokinetic blood-gathering for trial and blood-gathering for safety assessment due to Hypersensitivity to venipuncture
- •7) A smoker of 10 cigarettes/day on average over the past 3 months or a person who cannot abstain from smoking during the period from 3 days prior to the scheduled first administration of investigational product to close-out visit
- •8) A habitual drinker (>21 units/week, 1 unit = 10 g of pure alcohol) within 4 weeks prior to screening or a person who cannot abstain from alcohol consumption during the clinical trial
- •9) Individual having gastrointestinal diseases that can affect the absorption of drugs (Crohn’s disease, ulcers, acute or chronic pancreatitis, etc.) or having a history of gastrointestinal surgery (however, simple appendectomy or hernia surgery are excluded).
- •10) Subjects who have clinical significant diseases of liver, kidney, nervous system, immune system, respiratory system, endocrine system, or hemato·oncology, cardiology, mental disorder(Mood disorder, obsessive-compulsive disorder etc.) or who has past history(in the case of the liver disease, including subjects who have hepatitis viruses)
- •11) Vagotonia patient, asthma patient, hyperthyroidism patient, coronary artery obstruct patient, vasomotor incomplete patient, myocardial infarction patient, Severe cardiac disease patient, epilepsy and Parkinson's disease patient, patient who are treated with cholinesterase inhibitor, not recovered patient after surgery of gastrointestinal tract anastomosis
- •12) Subject who had some lab data below.
- •After the break in the sitting position measured vital signs, systolic blood pressure < 90 mmHg or > 150 mmHg or diastolic blood pressure < 60 mmHg or > 95 mmHg
- •13)Clinical laboratory test at screening
- •? AST(SGOT), ALT(SGPT) > above (upper limit of normal reference range)x 1.5
- •? Serum creatinine > above upper limit of normal reference range
- •? QTc >450 msec or clinically significant abnormal rhythm in electrocardiography
- •14) Drug abuse history or positive finding in urine drug screening
- •15) Subjects who do not agree with personally using appropriate method of contraception during trial.
- •- (IUD (Intrauterine device), IUS (Intrauterine system), vasectomy, tubal ligation, barrier method(a male condom, a female condom, a cervical cap, contraceptive diaphragms, contraceptive sponge etc.)
- •16) Subjects who have unusual eating habit(ex: continu
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