A Study to Compare the Pharmacokinetics of BR9003A and BR9003 in Healthy Adult Subjects
A Randomized, Open-label, Three-treatment, Six-sequence, Three-period, Crossover Clinical Study to Compare the Pharmacokinetic Characteristics Between Twice Daily Administration of BR9003A and Once Daily Administration of BR9003 in Healthy Adult Subjects
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Incheon、大韩民国
- Inha University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy adults aged 19 to 55 years at screening
- Those who weigh at least 50 kg at the time of screening and have a calculated body mass index (BMI) within the range of 18.0 to 29.0 kg/m2
- Determined to be eligible as subjects through physical examination and interview conducted in accordance with this protocol. In other words, those who have no congenital or chronic diseases and have no abnormal symptoms or findings based on medical examination results within the last 3 years
- Determined to be eligible as subjects as a result of clinical laboratory tests and electrocardiography performed according to this protocol
- Voluntarily decide to participate in the study and provide written consent to follow the study directions after listening to and fully understanding the detailed explanation on this study
Exclusion Criteria:
- Those who have clinically significant diseases or a history of the diseases associated with the cardiovascular system, respiratory system, liver, kidney, nervous system, endocrine system, blood/tumor, psychiatric diseases, or urinary system
- Those who have hypersensitivity reactions or a history of clinically significant hypersensitivity reactions to drugs containing varenicline, or drugs containing the same class ingredients, or other drugs
- Those with clinically significant hypotension (systolic blood pressure ≤ 90mmHg) or hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg) at the time of screening
- Those with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcer, etc.) or gastrointestinal surgery (however, simple appendectomy or hernia repair are excluded) that may affect the absorption of drugs
Any of the following results in the screening tests
- AST or ALT > 2 times the upper limit of the normal range
- Total bilirubin > 2.0 mg/dL
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2
- Those who continue to drink alcohol (>21 units/week; 1 unit = 10 g = 12.5 mL of pure alcohol), or are unable to abstain from drinking during the clinical study period
- Those who continue to smoke (>10 cigarettes/day) or cannot stop smoking during hospitalization during the clinical trial period
- Those who have participated in another clinical trial or bioequivalence test (the last day of administration of the investigational product or bioequivalence test drug) within 6 months prior to the first administration date
- Those who have donated whole blood within 60 days prior to the first day of administration or donated blood components (apheresis) within 30 days prior to the first day of administration or who have received a blood transfusion within 30 days
- Those who took any prescription drugs or herbal medicines within 14 days prior to the first day of administration or any over-the-counter (OTC) drugs within 7 days prior to the first day of administration (however, if other conditions are appropriate according to the judgment of the investigator, they may participate in the clinical trial.)
- Those who took drugs inducing and inhibiting drug-metabolizing enzymes, such as barbital, within 30 days prior to the study initiation
- Those who have been on a diet (especially grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 7 days prior to the first day of administration
- Pregnant woman, potentially pregnant woman, or breast-feeding woman
- Those who do not agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy using a medically acceptable methods of contraception* throughout the entire period from the date of the first administration of the investigational product to the end of the clinical trial
- Those who are unwilling or unable to comply with the dietary and lifestyle guidelines required for the clinical trial
- Those who have clinically significant abnormalities in the results of other clinical laboratory tests or who have been determined by the investigator to be ineligible to participate in the clinical trial due to other reasons (e.g., non-compliance with instructions, uncooperative attitude, etc.)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:序列 1
研究产品将根据第 1 期、第 2 期和第 3 期分配给每个序列组的治疗组(A、B、C)给药。 *序列 1:A-B-C |
Treatment group B: Once-daily oral administration of one BR9003 2mg tablet in the fasting state. Treatment group C: Once-daily oral administration of one BR9003 2mg tablet after a meal(high-fat meal) 30 minutes before the scheduled time of administration and finishing it. Treatment group A: Twice-daily oral administration of one BR9003A 1mg tablet in the fasting state |
实验性的:序列 2
研究产品将根据第 1 期、第 2 期和第 3 期分配给每个序列组的治疗组(A、B、C)给药。 *序列 2:A-C-B |
Treatment group B: Once-daily oral administration of one BR9003 2mg tablet in the fasting state. Treatment group C: Once-daily oral administration of one BR9003 2mg tablet after a meal(high-fat meal) 30 minutes before the scheduled time of administration and finishing it. Treatment group A: Twice-daily oral administration of one BR9003A 1mg tablet in the fasting state |
实验性的:序列 3
研究产品将根据第 1 期、第 2 期和第 3 期分配给每个序列组的治疗组(A、B、C)给药。 *序列 3:B-A-C |
Treatment group B: Once-daily oral administration of one BR9003 2mg tablet in the fasting state. Treatment group C: Once-daily oral administration of one BR9003 2mg tablet after a meal(high-fat meal) 30 minutes before the scheduled time of administration and finishing it. Treatment group A: Twice-daily oral administration of one BR9003A 1mg tablet in the fasting state |
实验性的:序列 4
研究产品将根据第 1 期、第 2 期和第 3 期分配给每个序列组的治疗组(A、B、C)给药。 *序列 4:B-C-A |
Treatment group B: Once-daily oral administration of one BR9003 2mg tablet in the fasting state. Treatment group C: Once-daily oral administration of one BR9003 2mg tablet after a meal(high-fat meal) 30 minutes before the scheduled time of administration and finishing it. Treatment group A: Twice-daily oral administration of one BR9003A 1mg tablet in the fasting state |
实验性的:序列 5
研究产品将根据第 1 期、第 2 期和第 3 期分配给每个序列组的治疗组(A、B、C)给药。 *序列 5:C-A-B |
Treatment group B: Once-daily oral administration of one BR9003 2mg tablet in the fasting state. Treatment group C: Once-daily oral administration of one BR9003 2mg tablet after a meal(high-fat meal) 30 minutes before the scheduled time of administration and finishing it. Treatment group A: Twice-daily oral administration of one BR9003A 1mg tablet in the fasting state |
实验性的:序列 6
研究产品将根据第 1 期、第 2 期和第 3 期分配给每个序列组的治疗组(A、B、C)给药。 *序列 6:C-B-A |
Treatment group B: Once-daily oral administration of one BR9003 2mg tablet in the fasting state. Treatment group C: Once-daily oral administration of one BR9003 2mg tablet after a meal(high-fat meal) 30 minutes before the scheduled time of administration and finishing it. Treatment group A: Twice-daily oral administration of one BR9003A 1mg tablet in the fasting state |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
AUCt
大体时间:0-72 hours after administration
|
Area under the plasma drug concentration-time curve from 0 to time t of BR9003 and BR9003A
|
0-72 hours after administration
|
Cmax
大体时间:0-72 hours after administration
|
Maximum concentration of drug in plasma of BR9003 and BR9003A
|
0-72 hours after administration
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- BR-VRNS-CT-102
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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