NCT07533539已完成1 期
A Randomized, Open, Single-dose, Crossover-design, Phase I Study to Evaluatethe Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of L03TD1 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
- AUCt
研究概览
简要总结
This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the pharmacokinetics and safety after co-administration of L03RD1 and L03RD2 or administration of L03TD1 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1) Subject is between 19 and 55 years of age, inclusive, at the time of screening.
- •2) Subjects who have a BMI between 18.0 and 29.9 kg/m², inclusive, at the time of screening (Body weight ≥50 kg for males, ≥45 kg for females).
- •3) Subjects who have a seated blood pressure at the time of screening between 90 and 139 mmHg systolic and between 60 and 89 mmHg diastolic, inclusive.
- •4) Subjects who do not have clinically significant congenital or chronic diseases and do not have pathological symptoms or findings as a result of internal medical examination. (if necessary, electroencephalography, electrocardiogram, chest and stomach endoscopy, or gastrointestinal radiography, etc.)
- •5) Subjects who are determined by the principal investigator(or the delegated investigator) to be suitable as a study subject based on the results of assessments performed during screening, such as diagnostic tests(e.g., hematology test, blood chemistry test, serology test, urinalysis) and electrocardiogram(ECG) conducted in accordance with the characteristics of the investigational product.
- •6) Subjects or their spouse or partner agree to use a highly effective contraceptive methods* (excluding hormonal agents) to rule out the possibility of pregnancy from the date of first administration of the investigational product until 14 days after the last administration of the investigational product. They also agree not to donate sperm or eggs.
- •* Highly effective contraceptive methods: intrauterine device (IUD), bilateral tubal occlusion, vasectomised partner, and sexual abstinence. However, periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Furthermore, the simultaneous use of a female condom and a male condom is not permitted.
- •7) Subjects who have voluntarily decided to participate and have signed the informed consent form after receiving sufficient explanation and understanding of the purpose and content of the study, the characteristics of the investigational product, and the expected adverse events.
排除标准
- •1) Subjects who have taken any drug that induces or inhibits drug metabolizing enzymes (e.g. barbiturates) within 1 month prior to the start of the study (date of first administration), or any drug that may affect this study within 10 days prior to the start of the study (date of first administration). (However, based on pharmacokinetic and pharmacodynamic characteristics such as drug interactions with the investigational product or the half-life of concomitant medications, the principal investigator (or the delegated investigator) will determine the subject's eligibility for participation)
- •2) Subjects who participated in another clinical trial or bioequivalence study and received an investigational product within 6 months prior to first administration of investigational product.
- •3) Subjects who have donated whole blood within 8 weeks, donated blood components within 2 weeks, or received a transfusion within 4 weeks prior to first administration of investigational product.
- •4) Subject who have a history of gastrointestinal resection that may affect drug absorption (excluding appendectomy and hernia surgery).
- •5) Subjects who meet any of the following criteria within 1 month prior to first administration of investigational product
- •a. Excessive alcohol consumption
- •More than 21 units/week for males
- •More than 14 units/week for females
- •(1 unit: 50 mL soju, 30 mL whiskey, or 250 mL beer)
- •b. Smoking more than 20 cigarettes per day
- •6) Subjects who have any of the following medical conditions
- •a. Known hypersensitivity to the active ingredient or any component of the investigational product
- •b. Heart failure or a history of heart failure
- •c. Active bladder cancer or history of bladder cancer
- •d. Hepatic impairment
- •e. Severe renal impairment
- •f. Uninvestigated macroscopic hematuria
- •g. Diabetic ketoacidosis, diabetic coma or pre-coma, Type 1 diabetes, or Type 2 diabetes
- •h. Severe infections, perioperative conditions, or moderate trauma
- •i. Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •7) Subjects who have a history of clinically significant mental illness.
- •8) Subjects who are judged by the principal investigator(or the delegated investigator) to be unsuitable for this clinical trial for reasons other than the above inclusion/exclusion criteria.
- •9) Female subjects who are suspected of being pregnant or breastfeeding.
研究组 & 干预措施
A (L03RD1/L03RD2 -> L03TD1)
Experimental
Administration of 1 tablet of L03RD1 and 2 tablets of L03RD2, and taking 14-day wash-out period, and then administration of 1 table of L03TD1
干预措施: L03RD2 (Drug)
A (L03RD1/L03RD2 -> L03TD1)
Experimental
Administration of 1 tablet of L03RD1 and 2 tablets of L03RD2, and taking 14-day wash-out period, and then administration of 1 table of L03TD1
干预措施: L03TD1 (Drug)
B (L03TD1 -> L03RD1/L03RD2)
Experimental
Administration of 1 table of L03TD1, and taking 14-day wash-out period, and then administration of 1 tablet of L03RD1 and 2 tablets of L03RD2
干预措施: L03RD1 (Drug)
B (L03TD1 -> L03RD1/L03RD2)
Experimental
Administration of 1 table of L03TD1, and taking 14-day wash-out period, and then administration of 1 tablet of L03RD1 and 2 tablets of L03RD2
干预措施: L03RD2 (Drug)
A (L03RD1/L03RD2 -> L03TD1)
Experimental
Administration of 1 tablet of L03RD1 and 2 tablets of L03RD2, and taking 14-day wash-out period, and then administration of 1 table of L03TD1
干预措施: L03RD1 (Drug)
B (L03TD1 -> L03RD1/L03RD2)
Experimental
Administration of 1 table of L03TD1, and taking 14-day wash-out period, and then administration of 1 tablet of L03RD1 and 2 tablets of L03RD2
干预措施: L03TD1 (Drug)
结局指标
主要结局
AUCt
时间窗: Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours
Cmax
时间窗: Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours
次要结局
- AUCinf(Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours)
- AUCt/AUCinf(Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours)
- Tmax(Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours)
- t1/2(Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours)
- CL/F(Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours)
研究者
研究点 (1)
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