NCT06744426已完成1 期
An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 4-period, Crossover Phase I Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015 and Co-administration of BR1015-3 and BR1015-2 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero to time τ
研究概览
简要总结
The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of BR1015 and co-administration of BR1015-3 and BR1015-2 in healthy volunteers under fasting conditions
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 weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
- •Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
- •Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial*(Except for hormone drugs) from the date of consent to 14 days after the last administration and disagrees to provide their sperm or ovum.
- •Methods of contraception accepted in clinical trial: Combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.
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 drugs 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 other clinical trials(including bioequivalence tests) and 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 gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
- •Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, 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
BR1015
Experimental
干预措施: BR1015 (Drug)
BR1015-2 + BR1015-3
Active Comparator
干预措施: BR1015-2 (Drug)
BR1015-2 + BR1015-3
Active Comparator
干预措施: BR1015-3 (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to time τ
时间窗: 0-72 hours after administration
Maximum concentration of drug in plasma
时间窗: 0-72 hours after administration
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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