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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pharmacokinetic variable - AUCt
研究概览
简要总结
This was 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.
详细描述
A total of 40 healthy volunteers will be enrolled to evaluate the pharmacokinetics and safety profiles of the study drug (one combination tablet of dapagliflozin 10 mg/pioglitazone 30 mg/metformin HCl 1000 mg) and the comparator (co-administration of dapagliflozin 10 mg, pioglitazone 30 mg, and metformin HCl 1000 mg, one tablet each, respectively) while fed.
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
- •Adults aged over 19 at the time of consent
- •Those who are eligible to participate in the clinical trial at the discretion of the principal investigator (or a subinvestigator) through laboratory tests such as hematology tests, blood chemistry tests, serology tests, urine tests, and electrocardiogram (ECG) tests that were planned/performed with specification to the investigational product.
- •Those who provided written consent after receiving sufficient explanations and fully understood the objective and details of this clinical trial, the characteristics of the investigational product, and the expected adverse events.
排除标准
- •Those who have administered investigational products within 6 months from the first dose administration date in another clinical trial (including bioequivalent studies) (The end of study date is based on the last dose administration date.)
- •Those who have undergone gastrointestinal surgeries or have gastrointestinal diseases (except appendectomy or hernia surgery) that may affect the absorption of the investigational products
- •Female subjects who are pregnant, suspected of pregnancy, or nursing
研究组 & 干预措施
Sequence A (R1+R2+R3 / T)
R1+R2+R3: BR3006A, BR3006B, and BR3006C; T:
BR3006
干预措施: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg (Drug)
Sequence A (R1+R2+R3 / T)
R1+R2+R3: BR3006A, BR3006B, and BR3006C; T:
BR3006
干预措施: Dapagliflozin 10 mg (Drug)
Sequence A (R1+R2+R3 / T)
R1+R2+R3: BR3006A, BR3006B, and BR3006C; T:
BR3006
干预措施: Pioglitazone 30 mg (Drug)
Sequence A (R1+R2+R3 / T)
R1+R2+R3: BR3006A, BR3006B, and BR3006C; T:
BR3006
干预措施: Metformin HCl 1000 mg (Drug)
Sequence B (T / R1+R2+R3)
T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C
干预措施: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg (Drug)
Sequence B (T / R1+R2+R3)
T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C
干预措施: Dapagliflozin 10 mg (Drug)
Sequence B (T / R1+R2+R3)
T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C
干预措施: Pioglitazone 30 mg (Drug)
Sequence B (T / R1+R2+R3)
T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C
干预措施: Metformin HCl 1000 mg (Drug)
结局指标
主要结局
Pharmacokinetic variable - AUCt
时间窗: [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]
Area under the drug concentration-time curve over the time interval of "BR3006"
Pharmacokinetic variable - Cmax
时间窗: [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]
Maximum plasma concentration of "BR3006"
次要结局
未报告次要终点