KCT0001812招募中未知
An Open-Label, One-Sequence Study to Evaluate the Effect of Gumiganghwaltang on the Pharmacokinetics of Caffeine after Oral Administration of Caffeine in Healthy Male Volunteers
Kyung Hee University Oriental Medical Center0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 8
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
- •Healthy adult male volunteers aged 19 to 45 years
- •- Subjects who have over 55kg and within ±20% of ideal body weight * IBW= (height (cm) - 100) × 0.9
- •- Subjects who provided written informed consent to participate in this study and voluntarily taken part
- •in during the entire study period
排除标准
- •- Subjects with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.
- •- Subjects who have gastrointestinal disease (Crohn’s disease, peptic ulcer, acute or chronic pancreatitis) which may affect absorption of GGT or who have past medical history in gastrointestinal surgery (excluding simple appendectomy or herniotomy).
- •- Subjects who have hypersensitivity to clinical trial medications or additives, or who have past medical history of clinically significant hypersensitive reaction.
- •- Subjects who are considered inappropriate subjects after screening test(medical history, physical examination, vital sign, ECG, laboratory test, etc)
- •- Subjects who show any following result in clinical laboratory test (Hemoglobin < 13.0 g/dL, AST or ALT > 1.5 times of upper limit of normal range / Total bilirubin > 1.5 times of upper limit of normal range / CPK > over 1.5 times of upper limit of normal range / eGFR(estimated Glomerular Filtration Rate) by using MDRD(Modification of Diet in Renal Disease) < 60 mL/min/1.73 m2)
- •- Systolic blood pressure = 140mmHg or = 90mmHg, diastolic blood pressure = 90mmHg or = 60mmHg after taking 5 minitues of rest.
- •- Subjects who have drug abuse history
- •- Subjects who take too much caffeine, alcohol and smoking (caffeine > 5 cups/day, alcohol > 210g/week, cigarette > 10 pieces/day)
- •- Subjects who have taken other clinical medication from another clinical trial within 3-months period prior to the first administration of the study medication.
- •- Subjects who took drugs like barbiturates which induce or inhibit the enzyme involved in drug metabolism within 30 days.
- •- Subjects who donated whole blood within 60 days or specific components of the blood within 30 days before taking clinical trial medication.
- •- Subjects who took food containing grapefruit within 7 days before being administered clinical trial medication
- •- Subjects who took Western medicine or herb medicine before being administered clinical trial medication or subjects who took OTC or vitamins within 7 days before being administered clinical trial medication.
- •- Subjects who are considered inappropriate for other reasons
研究者
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