NCT06889064已完成1 期
A Randomized, Open-label, Single Oral Dose, Three-arm, Parallel Design, Phase 1 Study to Evaluate the Pharmacokinetic, Pharmacodynamic Characteristics and the Safety After Administration by Doses of BR1400-1, BR1400-2, BR1400-3 in Healthy Volunteers
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
- 28
- 试验地点
- 1
- 主要终点
- AUCt
研究概览
简要总结
The purpose of this clinical study is to evaluate the pharmacokinetic, pharmacodynamic characteristics and the safety after administration by doses of "BR1400-1", "BR1400-2", "BR1400-3" in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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) of 18.0kg/m2 to 30.0kg/m2 at screening visit.
- •For men, Those who weigh 50 kg or more
- •For women, Those who weigh 45 kg or more
- •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* from the date of consent to 7 days after the last administration and disagree 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.
- •Those who spontaneously decide to participate and sign written consent to observe the subject's compliance during this clinical trial 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.
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 ethical drugs, over the counter drugs, herbal medicines, health functional foods concerned about affecting this clinical trial within 10 days before the first administration date. (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 and administered their investigational products within 6 months before 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 diseases (ex. crohn's disease, ulcerative colitis, etc.) or gastrointestinal resection (Except for simple appendectomy, hernia surgery) that may affect the absorption of drugs or have gastrointestinal diseases
- •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 before the first administration date
- •In the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman.
研究组 & 干预措施
BR1400-1
Experimental
干预措施: BR1400-1 (Drug)
BR1400-2
Experimental
干预措施: BR1400-2 (Drug)
BR1400-3
Experimental
干预措施: BR1400-3 (Drug)
结局指标
主要结局
AUCt
时间窗: 0-48 hours after administration
Area under the plasma drug concentration-time curve from 0 to time t
Cmax
时间窗: 0-48 hours after administration
Maximum concentration of drug in plasma
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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