A Randomized, Open-label, Single-dose, Two-sequence, Two-period, Cross-over Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of L04TD1 and L04RD1 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
- 50
- 试验地点
- 1
- 主要终点
- AUCt
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 administration of L04RD1 or administration of L04TD1 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 64 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 at the screening visit and has a body mass index (BMI) of 18.0~29.9 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 30 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 30 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
A (L04RD1 -> L04TD1)
Administration of 1 tablet of L04RD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04TD1
干预措施: L04RD1 (Drug)
A (L04RD1 -> L04TD1)
Administration of 1 tablet of L04RD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04TD1
干预措施: L04TD1 (Drug)
B (L04TD1 -> L04RD1)
Administration of 1 tablet of L04TD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04RD1
干预措施: L04TD1 (Drug)
B (L04TD1 -> L04RD1)
Administration of 1 tablet of L04TD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04RD1
干预措施: L04RD1 (Drug)
结局指标
主要结局
AUCt
时间窗: Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
Cmax
时间窗: Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
次要结局
- AUCt/AUCinf(Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours)
- t1/2 (Half-life)(Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours)
- AUCinf (Area under the plasma concentration-time curve from time 0 to infinity)(Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours)
- Tmax (Time of peak plasma concentration)(Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours)
- CL/F(Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours)