A Randomized, Open-label, Single Dose, Two-way Replicate Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-1" and "BR1019-2" in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-1" and "BR1019-2" in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit
- •In case of a male subject, Those who weigh 50 kg or more
- •In case of a female subject, Those who weigh 45 kg or more
- •Those who decide to voluntarily participate after listening to and understanding the detailed explanation of this clinical trial and who sign a written consent to comply with the subject's precautions during this clinical trial.
排除标准
- •Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken ETC, OTC, Oriental medicine, Health functional food concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
- •Those who have participated in bioequivalence tests or other clinical trials administered their investigational products within 6 months prior to the first administration date. (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
- •Those who have a medical history of gastrectomy(Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
- •Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or its products, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
- •In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
研究组 & 干预措施
Sequence Group A
The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4.
*Sequence Group A [Period 1, 3] Co-administration of BR1019-1(R1) and BR1019-2(R2). [Period 2, 4] Administration of BR1019(T)
干预措施: BR1019 (Drug)
Sequence Group A
The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4.
*Sequence Group A [Period 1, 3] Co-administration of BR1019-1(R1) and BR1019-2(R2). [Period 2, 4] Administration of BR1019(T)
干预措施: BR1019-1 (Drug)
Sequence Group A
The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4.
*Sequence Group A [Period 1, 3] Co-administration of BR1019-1(R1) and BR1019-2(R2). [Period 2, 4] Administration of BR1019(T)
干预措施: BR1019-2 (Drug)
Sequence Group B
The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4.
*Sequence Group B [Period 1, 3] Administration of BR1019(T) [Period 2, 4] Co-administration of BR1019-1(R1) and BR1019-2(R2).
干预措施: BR1019 (Drug)
Sequence Group B
The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4.
*Sequence Group B [Period 1, 3] Administration of BR1019(T) [Period 2, 4] Co-administration of BR1019-1(R1) and BR1019-2(R2).
干预措施: BR1019-1 (Drug)
Sequence Group B
The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4.
*Sequence Group B [Period 1, 3] Administration of BR1019(T) [Period 2, 4] Co-administration of BR1019-1(R1) and BR1019-2(R2).
干预措施: BR1019-2 (Drug)
结局指标
主要结局
Cmax
时间窗: 0-48 hours after administration
Maximum concentration of drug in plasma
AUCτ
时间窗: 0-48 hours after administration
Area under the concentration-time curve from time zero to time τ
次要结局
未报告次要终点