NCT03787043已完成1 期
A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Evaluate the Effect of Food on the Safety and Pharmacokinetics of Fixed-dose Combination of MP-513 10mg and Metformin XR 750mg in Healthy Male 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
- 发起方
- Handok Inc.
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUC of MP-513 and metformin
研究概览
简要总结
The purpose of this study is to compare the safety and pharmacokinetic characteristics of fixed-dose combination of MP-513 10mg and metformin XR 750mg administered in a high fat fed state versus fasting state to healthy male volunteers.
详细描述
- Randomized, open-label, single-dosing, two-treatment, two-sequence, two-period, crossover design
- Wash-out period: 14 days from the first dosing
- Drug concentration analytical device: UPLC-MS/MS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A healthy male adult at the age of 20 to 45 (both inclusive) at the time of screening test.
- •Body weight equal to or greater than 55 kg and calculated ideal body weight (IBW) within ±20%
- •An individual who has been given and fully understood detailed explanations about this study, decides to participate in the study of his own will, and provides written informed consent to comply with instructions.
排除标准
- •History or presence of any clinically significant diseases in the hepatobiliary, renal, nervous(central or peripheral), respiratory, hemato-oncology, cardiovascular, urinary, musculoskeletal, immune, ear, nose and throat (ENT), mental, and, particularly, endocrine systems (e.g., diabetes mellitus, hyperlipidemia, etc.).
- •History of any gastrointestinal disease that may affect absorption of the study drug (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgeries (except for simple appendectomy or hernia repair).
- •Hypersensitivity to MP-513 or drugs containing metformin or other drugs in the same class as ingredients or to other drugs
- •Vital signs in a sitting position corresponding to at least one of the following criteria: systolic blood pressure ≥ 140 mmHg or < 90 mmHg, or diastolic blood pressure ≥ 95 mmHg or < 60 mmHg.
- •Serum creatine > upper limit of reference range
- •Required to refrain from food intake for at least 24 hours during the study period due to surgery or religious reason.
- •History or presence of drug abuse.
- •Administration of drugs that either induce or inhibit drug metabolizing enzymes, such as barbitals, within 1 month prior to the first dosing.
- •Intake of food or beverage containing grapefruit or cranberry within 1 week prior to the first dosing.
- •Administration of any ethical drugs or traditional Korean herbal medicines within 2 weeks or any over-the-counter drugs or vitamin products within 1 week prior to the first dosing
- •An individual who participated in another clinical trial and was administered any investigational product within 3 months prior to the first dosing.
- •Whole blood donation within 2 months, apheresis donation within 1 month, or blood transfusion within 1 month prior to the first dosing.
- •An individual who drinks excessive amounts of alcohol or who cannot stop drinking alcohol from 24 hours prior to hospital admission through to hospital discharge.
- •Having smoked 10 cigarettes/day or more on average over the past 3 months.
研究组 & 干预措施
Sequence Group A
Experimental
- 1st period: FDC(MP-513 10mg/Metformin XR 750mg) under fasted
- 2nd period: FDC(MP-513 10mg/Metformin XR 750mg) under fed
干预措施: FDC(MP-513 10mg/Metformin XR 750mg) (Drug)
Sequence Group B
Experimental
- 1st period: FDC(MP-513 10mg/Metformin XR 750mg) under fed
- 2nd period: FDC(MP-513 10mg/Metformin XR 750mg) under fasted
干预措施: FDC(MP-513 10mg/Metformin XR 750mg) (Drug)
结局指标
主要结局
AUC of MP-513 and metformin
时间窗: 0(pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose for each period(a total of 36 times, with 18 times per period)
PK
Cmax of MP-513 and metformin
时间窗: 0(pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose for each period(a total of 36 times, with 18 times per period)
PK
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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