NCT06890299已完成1 期
An Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between Single Oral Administration of BR3006 and Co-administration of BR3006A, BR3006B and BR3006C 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
- AUCt
研究概览
简要总结
The purpose of this clinical study is to evaluate the pharmacokinetics and safety between single oral administration of BR3006 and co-administration of BR3006A, BR3006B and BR3006C in healthy adult volunteers under fed 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 who have body mass index (BMI) of 18.0kg/m2 to 30.0kg/m2 at screening visit.
- •For men, Those who weigh 55 kg or more
- •For women, Those who weigh 50 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 14 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 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 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 a medical history of gastrointestinal resection (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
- •Those who have participated in other clinical trials(including bioequivalence tests) 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)
- •In the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman.
研究组 & 干预措施
BR3006
Experimental
干预措施: BR3006 (Drug)
BR3006A+BR3006B+BR3006C
Active Comparator
干预措施: BR3006A (Drug)
BR3006A+BR3006B+BR3006C
Active Comparator
干预措施: BR3006B (Drug)
BR3006A+BR3006B+BR3006C
Active Comparator
干预措施: BR3006C (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...
相似试验
已完成
1 期
A Study to Evaluate the Pharmacokinetics and Safety Between Single Administration of "BR6002" and Coadministration of "BR6002A" and "BR6002B" Under Fed Conditions in Healthy Adult VolunteersGastric or Duodenal UlcerNCT05959499Boryung Pharmaceutical Co., Ltd40
已完成
1 期
A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fed Conditions in Healthy Adult VolunteersType2 Diabetes MellitusNCT06289933Boryung Pharmaceutical Co., Ltd40
已完成
1 期
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015 and Co-administration of BR1015-3 and BR1015-2 Under Fed ConditionsEssential HypertensionNCT06744439Boryung Pharmaceutical Co., Ltd49
已完成
1 期
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015 and Co-administration of BR1015-1 and BR1015-2 in Healthy Volunteers Fed ConditionsEssential HypertensionNCT06744062Boryung Pharmaceutical Co., Ltd48
已完成
1 期
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy VolunteersHypertensionNCT06008015Boryung Pharmaceutical Co., Ltd44