NCT05959499已完成1 期
An Open-label, Randomized, Fed, Single-dose, 2-sequence, 4-period, Full Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety Between Single Administration of "BR6002" and Coadministration of "BR6002A" and "BR6002B" in Healthy Adult 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
- 40
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this clinical trial is evaluate the pharmacokinetics and safety between single administration of "BR6002" and coadministration of "BR6002A" and "BR6002B" under fed conditions in healthy adult volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who weigh 55 kg or more for men and 50 kg or more for women and have body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 at screening.
- •Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception (In the case of a female subject, hormone drugs is excluded) accepted in clinical trial from the date of the first administration of the investigational products to 7 days after the last administration and disagrees to provide their sperm or ovum.
- •Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used
- •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.
排除标准
- •Those who have clinically significant diseases or past history of the gastrointestinal system, cardiovascular system, endocrine system, respiratory system, hemato-oncologic disease, infectious disease, kidney & genitourinary system, neuropsychiatric system, musculoskeletal system, immune system, ENT system, skin system, ophthalmic system.
- •Those who have a medical history of gastrointestinal surgery (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
- •Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 1month prior to the first day of administration or have taken ETC, OTC, herbal medicine and health functional foods 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)
- •Those who have participated in other clinical trials or bioequivalence tests and administered their investigational products within 6 months prior to the first administration date.
- •Those who are unable to consume high-fat meals provided during this clinical trial.
- •In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
研究组 & 干预措施
BR6002A+BR6002B
Active Comparator
干预措施: BR6002A (Drug)
BR6002A+BR6002B
Active Comparator
干预措施: BR6002B (Drug)
BR6002
Experimental
干预措施: BR6002 (Drug)
结局指标
主要结局
Cmax
时间窗: 0-24 hours after administration
Maximum concentration of drug in plasma
AUCτ
时间窗: 0-24 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
研究者
研究点 (1)
Loading locations...
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