NCT05363592已完成1 期
A Randomized, Open, Single-dose, Crossover-design, Phase I Study to Evaluate Bioequivalence After Co-administration of ALO 12.5 mg and MET XR 500 mg or Administration of CT-L01 12.5/500 mg in Healthy 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
- Celltrion
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUClast (Area under the plasma concentration-time curve)
研究概览
简要总结
This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject aged 19 to 50 years, at screening
- •A subject who weighs 50 kg or more at the screening visit and has a body mass index (BMI) of 18.0~30.0 kg/m2
- •A subject who is judged to be eligible to participate by the results of screening tests (vital signs, clinical laboratory tests, 12-lead ECG, etc.) by the principal investigator within 28 days before the first administration of the investigational drug
- •A subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 28 days after the last dose of the investigational drug
- •A subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, thge characteristics of the investigational drugs, expected adverse reactions, and etc.
排除标准
- •A subject who has a history or present symptoms of clinically significant liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or psychiatric disease
- •A subject who has an acute illness within 28 days prior to the first dose of investigational drug
- •A subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
- •A subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first administration
- •A subject who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the investigational drug
- •A subject who is judged unsuitable to participate in this study by the principal investigator
研究组 & 干预措施
CT-L01 12.5/500 mg FDC Tablet
Experimental
Alogliptin Benzoate 12.5 mg/Metformin HCl XR 500 mg, FDC Tablet
干预措施: CT-L01 12.5/500 mg (Drug)
Alogliptin Benzoate 12.5 mg, Metformin HCl XR 500 mg
Active Comparator
- Alogliptin Benzoate 12.5 mg
- Metformin HCl XR 500 mg
干预措施: Alogliptin Benzoate 12.5 mg (Drug)
Alogliptin Benzoate 12.5 mg, Metformin HCl XR 500 mg
Active Comparator
- Alogliptin Benzoate 12.5 mg
- Metformin HCl XR 500 mg
干预措施: Metformin HCl XR 500 mg (Drug)
结局指标
主要结局
AUClast (Area under the plasma concentration-time curve)
时间窗: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
Cmax (Peak Plasma Concentration)
时间窗: Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours
次要结局
- AUCinf (Area under the plasma concentration-time curve from time 0 to infinity)(Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours)
- AUClast/AUCinf(Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours)
- Tmax (Time of peak plasma concentration)(Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours)
- t1/2 (Half-life)(Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours)
研究者
研究点 (1)
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