A Two-arm, Open-label, Single-sequence, Multiple-dose, Cross-over Phase 1 Study to Evaluate the Pharmacokinetic Interaction and Safety of CTL0801 and CTL0802 Compared to Coadministration in Healthy Adult Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- AUCτ,ss
研究概览
简要总结
This is a two-arm, open-label, single-sequence, multiple-dose, cross-over phase 1 study to evaluate the interaction between two investigational drugs by comparing and analyzing the pharmacokinetic interaction and safety of CTL0801 and CTL0802 at steady state when administered alone or in combination with repeated oral doses in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •A subject who weighs 50 kg or more (45 kg or more for women)
- •A subject who does not have clinically significant congenital or chronic diseases
- •A subject who is judged to be eligible to participate by the results of diagnostic tests by the principal investigator
- •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 7 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, the characteristics of the investigational drugs, and expected adverse reactions
排除标准
- •A subject who has a known digestive system, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and genitourinary system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmic system or has any past history of them
- •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 of the first administration or has taken drugs that may affect the study within 10 days of the first administration (however, participation can be possible considering pharmacokinetic·pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs etc)
- •A subject who has participated and administered other investigational drugs in other clinical trials or bioequivalence studies within 6 months of the first administration
- •A subject who is judged ineligible for participation in this study by the principal investigator
- •A female volunteer who is pregnant or lactating
研究组 & 干预措施
Arm A
CTL0801 (Azilsartan) QD, 4days → CTL0801 (Azilsartan) + CTL0802 (Rosuvasatin) QD, 7days
干预措施: CTL0801 (Azilsartan) (Drug)
Arm A
CTL0801 (Azilsartan) QD, 4days → CTL0801 (Azilsartan) + CTL0802 (Rosuvasatin) QD, 7days
干预措施: CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin) (Drug)
Arm B
CTL0802 (Rosuvasatin) QD, 7days → CTL0801 (Azilsartan) + CTL0802 (Rosuvasatin) QD, 7days
干预措施: CTL0802 (Rosuvastatin) (Drug)
Arm B
CTL0802 (Rosuvasatin) QD, 7days → CTL0801 (Azilsartan) + CTL0802 (Rosuvasatin) QD, 7days
干预措施: CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin) (Drug)
结局指标
主要结局
AUCτ,ss
时间窗: predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose
Cmax,ss
时间窗: predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose
次要结局
- Tmax,ss(predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose)
- Cmin,ss(predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose)