KCT0004007已完成未知
A randomized, open-label, single dose, 3-period, 3-sequence crossover study to compare the pharmacokinetics and safety/tolerability of BS-105 enteric-coated tablet A” or BS-105 enteric-coated tablet B” of Bio-Synectics to original drug in healthy male subjects (Pilot study)
Bio-Synectics0 个研究点目标入组 9 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
- 9
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 50(Year)（—）
- 性别
- Male
入选标准
- •Inclusion Criteria:
- •1. Healthy male, 19 years= Age = 50 years at the time of screening
- •2. 55.0 kg = Body weight = 90 kg and 18.0 kg/m² = BMI = 27.0 kg/m²
- •* BMI = Body weight(kg)/{Height(m)}²
- •3. Subject who had decided to participate in the clinical trial with willingness after fully understanding the clinical trial after in-depth explanation and signed an informed consent form before participating in the screening procedure
- •4. Subject who has no congenital or chronic diseases and no abnormal symptoms or signs based on medical examinations (if needed, EEG, ECG, thoracoscopy and gastroscopy, or gastrointestinal radiology examination)
- •5. Subject who is suitable for the clinical trial determined by investigator's judgement based on physical examination, laboratory tests, paper interview, etc.
排除标准
- •1. Subject who has a clinically significant hepatic, renal, nervous, respiratory, endocrine, haemato-oncology, cardiovascular, urinary, or psychiatric diseases or who has a medical history of these diseases
- •2. Subject who has or has a history of gastrointestinal diseases(except gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease)or surgeries(except for simple appendicitis or hernia) which can affect the pharmacokinetics and safety of investigational products
- •3. Subject who has hypersensitivity to posaconazole and any other drugs(aspirin, antibiotics, and so on) or has a history of clinically significant hypersensitivity
- •4. Subject who is Hepatitis B, Hepatitis C, or HIV- positive
- •5. Subject who had following results after examinations
- •5.1) Total bilirubin, AST(GOT). ALT(GPT) > 1.5 x upper limit of normal range at the time of screening
- •5.2) Systolic blood pressure(SBP) < 90 mmHg or SBP>150 mmHg, Diastolic blood pressure(DBP) < 50 mmHg or DBP>95 mmHg), or pulse rate <45 beats/min or pulse rate >100 beats/min at the time of screening (Vital signs measured in a seated position after resting more than 5 minutes)
- •5.3) QTc>450 msec, PRinterval>200 msec, QRSinterval>120 msec at ECG test
- •5.4) Other clinically significant findings
- •6. Subject who has a history of drug abuse
- •7. Subject who took (However, if the other conditions are reasonable according to the judgment of the investigator, the subject can participate in the clinical trial) or is expected to take any ETC(Ethical Drug) or oriental medicine within 2 weeks before the first dosing
- •8. Subject who took(However, if the other conditions are reasonable according to the judgment of the investigator, the subject can participate in the clinical trial) or is expected to take any OTC(Over-the-counter Drug), health functional food, vitamin within 1 week before the first dosing
- •9. Subject who took medicines that are known to induce or inhibit drug metabolizing enzymes, including barbiturates, within 1 month before the first dosing
- •10. Subject who took any other investigational product by participating in other clinical trials within 6 months before the first dosing
- •11. Subject who has donated whole blood or blood components within 2 months or 1 month, respectively, or has been transfused blood within 1 month before the first dosing
- •12. Subject who takes excessive caffeine (more than 5 units/day) or continually drinks alcohol (more than 21 units/week, 1unit = 10 g of pure alcohol), or cannot stop drinking alcohol during hospitalization period
- •13. Subject who takes or cannot stop taking food containing grapefruit from 24 hours before hospitalization and until being discharged from the hospital
- •14. Subject who cannot stop taking food containing caffeine (e.g. coffee, tea(black tea, green tea, etc.), carbonated beverage, coffee flavored milk, or energy drink, etc.) from 24 hours before hospitalization and until being discharged from the hospital
- •15. Subject who cannot perform clinically acceptable contraception during the clinical trial
- •16. Subject who is inappropriate for participating in the clinical trial by the judgement of the investigator based on laboratory test results or any other reasons
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