KCT0006146招募中未知
A clinical study to evaluate the effect of renal impairment of the pharmacokinetics of oral administration of Factive Tablet 320mg(Gemifloxacin mesylate)
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 19?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Control group A-healthy subjects
- •1) A person who is 19 years of age or older when visiting a screening.
- •2) A person who does not have clinically meaningful congenital or chronic diseases during a screening visit and does not have any pathological symptoms or findings as a result of an internal examination.
- •3) A person who weighs more than 50 kg and less than 90 kg and has a BMI of more than 20.0 kg/m2 and less than 45.0 kg/m2 during a screening visit.
- •BMI (kg/m2) = Weight (kg) / {length (m)}^2
- •4)A person who has signed a consent form according to his/her free will after hearing and understanding the purpose, contents, characteristics of medicine, and expected adverse reactions.
- •Test groups B, C and D-subjects with renal impairment
- •1) A person who is 19 years of age or older when visiting a screening.
- •2) A person who does not have clinically meaningful congenital or chronic diseases during a screening visit and does not have any pathological symptoms or findings as a result of an internal examination.
- •3) A person who weighs more than 50 kg and less than 90 kg and has a BMI of more than 20.0 kg/m2 and less than 45.0 kg/m2 during a screening visit.
- •BMI (kg/m2) = Weight (kg) / {length (m)}^2
- •4) Patients with severe, moderate or mild renal impairment with ‘15 = eGFR < 30 mL/min/1.73m2’ or ‘30 = eGFR < 60 mL/min/1.73m2’ or ‘60 = eGFR < 90 mL/min/1.73m2’(using the MDRD formula) during a screening visit.
- •5) Chronic renal impairment patients that are stable and have no sudden changes in renal function status for 3 months before screening
- •6) A person who has signed a consent form according to his/her free will after hearing and understanding the purpose, contents, characteristics of medicine, and expected adverse reactions.
排除标准
- •1) A person who has a history of clinically significant diseases corresponding to digestive systems, cardiovascular systems, endocrine systems, respiratory systems, blood and tumors, infectious diseases, kidney and urinary organisms, mental and nervous systems, musculoskeletal systems, immune systems, otolaryngology, skin systems, and ophthalmology systems.
- •2) A person who has a history of gastrointestinal surgery (except simple appendectomy or hernia surgery) or has gastrointestinal diseases (cron disease, ulcer, acute or chronic pancreatitis) that can affect the absorption of drugs.
- •3) Those with a history of tendonitis, tendon rupture, etc. due to investigational drugs and quinolone antimicrobial agents
- •4) Those who have a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs and other drugs (aspirin, nonsteroidal anti-inflammatory drugs, antibiotics, etc.) including ingredients such as investigational drugs and quinolone antibiotics
- •5) Those who showed the following results in the screening
- •- Those who exceed 2 times the upper limit of the normal range of AST (SGOT), ALT (SGPT)
- •- Those whose exceed 1.1 times the upper limit of the normal range of Serun Creatinine level
- •- Repeatedly measured QTc interval> 450 ms
- •- Positive reaction as a result of serum tests (HBs-Ag, Anti-HCV Ab, Anti-HIV, VDRL)
- •- Those with a history of substance abuse
- •6) systolic blood pressure <90 mmHg or >150 mmHg or diastolic blood pressure <60 mmHg or> 100 mmHg in the vital signs measured in the seat after rest for more than 3 minutes
- •7)Those who have used investigational drugs and quinolone antibacterial drugs within 6 weeks prior to the administration of the investigational drug
- •8)Those who took preion drugs or herbal medicines within 2 weeks prior to administration of the investigational drug, or took any OTC drug or health functional food or vitamin formulation within 1 week.
- •(However, if the administration of the drug does not affect the safety and pharmacokinetics, you can participate in the clinical trial. refer to the Concomitant Drugs section)
- •9) People who have an abnormal diet that may affect the absorption, distribution, metabolism, and excretion of drugs, or who eat foods that may affect drug metabolism.
- •10) A person who participated in other clinical trials or biological equivalence tests within six months before the commencement of the test (first date of administration) and administered medicines for clinical trials
- •11) A person who donated whole blood within two months (first date of administration) or donated ingredients within one month, or received blood transfusion within one month.
- •12) Those who continue to drink alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) or who cannot stop drinking from the time of written consent to the time of PSV
- •13) Smokers with an average of more than 10 per day for the last 3 months or who cannot quit smoking from 24 hours before administration to the time of the last blood collection
- •14) Those who have consumed foods containing grapefruit (grapefruit) from 48 hours before administration of the investigational drug to the time of PSV, and those who cannot refrain from eating foods containing grapefruit (grapefruit) during this period
- •15) Those who ingest caffeine-containing foods from 24 hours before administration of the investigational drug to the time of the last blood collection, and those who cannot prohibit the intake of
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