An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of IN-C009 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
This study was conducted as a randomized, open-label, single-dose, crossover study design. All participants were randomly allocated for group A (Period 1: Individual components (ICs), period 2: FCDP) and group B (Period 1: FCDP, period 2: ICs), and each group was administered either a single dose of IN-C009 (FCDP, dapagliflozin 10mg/linagliptin 5 mg) (HK inno.N., Seoul, Korea) or co-administration of a single dose of dapagliflozin (Forxiga 10 mg, AstraZeneca, Cambridge, England, UK) and linagliptin (Trajenta 5mg, Beringer-Ingelheim, Ingelheim, Germany) after at least 10 hours of overnight fasting. After the 28 days of the washout period, the participants received the opposite treatment (Group A: IN-C009; Group B: dapagliflozin and linagliptin). The dosage of dapagliflozin and linagliptin in the study is commercially used and recommended amount for the control of T2DM currently.
On the day 1 (the day of each drug administration), the serial blood samples were drawn immediately before (0 h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for dapagliflozin), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for linagliptin) after the each dosing to assess pharmacokinetics of each drugs.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age between 19 to 45 years;
- •body weight more than 50 kg
排除标准
- •a history or evidence of hepatic, renal, gastrointestinal, or hematological abnormality;
- •hepatitis B, hepatitis C, syphilis, or HIV infection;
- •a history of hypersensitivity to dapagliflozin and/or linagliptin;
- •clinically significant allergic disease; alcohol or drug abuse;
- •heavy smoker (more than ten cigarettes per day);
- •use of any medication within 30 days before the start of the study that may affect the study results.
研究组 & 干预措施
Period 1: Individual components (ICs), period 2: FCDP
Period 1: Individual components (ICs), period 2: FCDP
干预措施: FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin (Drug)
Period 1: FCDP, period 2: ICs
Period 1: FCDP, period 2: ICs
干预措施: FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin (Drug)
结局指标
主要结局
AUC
时间窗: 72 hours
area under plasma concentration versus time curve
Cmax
时间窗: 72 hours
peak plasma concentration
次要结局
- Vd(72 hours)
- Tmax(72 hours)
- half-life(72 hours)
- CL(72 hours)
研究者
Ji-Young Park
Professor
Korea University Anam Hospital