KCT0008374已完成Unknown
A Phase I, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Effect of JBPOS0101 on the Pharmacokinetics of Midazolam and the Interaction between Carbamazepine and JBPOS0101 in Healthy Subjects
Bio-Pharm Solutions0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 45(Year)（—）
- 性别
- All
入选标准
- •1. Healthy male or female volunteers at the age of 19–45 years old at screening
- •2. Body weight = 50.0 kg and body mass index (BMI) within the range of 19.0–30.0 kg/m2 at screening
- •BMI = Body weight (kg)/(Height [m])2
- •3. A female participant who was not pregnant or breastfeeding or in infertility due to surgery with the absence of ovary and/or uterus (bilateral tubal obstruction, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, etc.)
- •4. Participants who voluntarily decided to participate in the study after receiving and fully understanding detailed information on the study and provided written informed consent to comply with study instructions.
- •5. Participants evaluated to be eligible by the investigator.
排除标准
- •1. Participants who had a clinically significant disease or history in hepatic, renal, neurological, immunologic, respiratory (sleep apnea syndrome, acute respiratory failure), metabolic disease or hemato-oncology, cardiovascular disease (heart failure, myocardial infarction), psychiatric disease (mood disorder, obsessive-compulsive disorder, etc.)
- •2. Participants who had any history or presence of a gastrointestinal disease (gastrointestinal ulcer, gastritis, gastric cramp, gastro-esophageal reflux disease, Crohn’s disease, etc.) which may affect the safety and PK/pharmacodynamics (PD) of the IP and any history of surgery in gastrointestinal system (except for simple appendectomy or herniotomy)
- •3. Participants who had any history of clinically significant hypersensitivity (including status asthmaticus, anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, etc.) to drugs associated with the IP or food assessed by the investigators
- •4. Participants who had a hypersensitivity or allergy to MDZ and benzodiazepines or CBZ
- •5. Participants who had any history or presence of a condition that might increase the participant risk assessed by the investigator according to the package insert of MDZ or CBZ
- •6. Any abnormalities at screening:
- •- AST (SGOT), ALT (SGPT) > 1.5 x upper limit of normal
- •- A positive result in serum tests (Syphilis tests, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) antigen-antibody test)
- •- Other clinically significant abnormalities
- •7. Participants who had a history of severe injury or planned to have a surgery within 12 weeks before screening
- •8. Participants who had a history of suicidal behavior and/or ongoing suicidal ideation as assessed by the C-SSRS
- •9. Participants who had a history of drug abuse or a positive result for drugs with abuse potential in the urine drug test at screening
- •10. Participants who had a past or planned treatment with any prescription drugs or herbal medicine within 2 weeks, or any over the counter drugs, health functional foods, or vitamin supplements within 1 week prior to the first IP administration day (individual who was eligible based on other criteria may participate in the study at the discretion of the investigator)
- •11. Participants who had taken an inducer or inhibitor of any drug metabolic enzyme such as barbiturates, etc. within 1 month prior to the first IP administration day
- •12. Participants who had participated in any other clinical study (including bioequivalence study) within 6 months prior to the first IP administration day
- •13. Participants who donated the whole blood within 2 months or the component blood within 1 month, or those who received the blood transfusion within 1 month prior to the first IP administration day
- •14. Participants who continuously consumed alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) within 1 month prior to the first IP administration day or were not able to avoid drinking during the study period from 3 days prior to the first IP administration day
- •15. Current smokers (individuals who stopped smoking at least 3 months prior to the first IP administration day could be included.) or participants who were not able to stop smoking during the study period at least 3 months prior to the first IP administration day
- •16. Participants who were not able to avoid consuming grapefruit-containing food during the study period from 7 days prior to the first IP administration day
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