NCT05236998已完成1 期
A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of SID1903 (Fixed-dose Combination of Dapagliflozin and Sitagliptin) or Loose Combination in Healthy Adult Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of SID1903 and SID1903-R1/SID1903-R2 in healthy adult 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
- •Healthy subjects aged between 19 years and 55 years(inclusive)
- •Subjects weighing at least 50.0 kg and no more than 100 kg (inclusive) with a BMI between 18.5 kg/m2 and 30.0 kg/m2 (inclusive)
- •Subjects with neither congenital nor chronic diseases requiring treatment, and no abnormal symptoms or findings upon medical examination
- •Subjects considered eligible for the study participation in accordance to the results of vital signs, physical examinations, 12-lead ECG, clinical laboratory tests (including hematology, blood chemistry, urinalysis, serology, etc.) and urine drug screening conducted at the time of screening, based on the investigational product (IP) characteristics
- •Subjects who has a full understanding in participation of the study, voluntarily provide a written consent in participation, and give full agreement in following the subject guidelines throughout the entire study period
排除标准
- •Subjects with any clinically significant hepatic, renal, nervous, respiratory, endocrine, circulatory, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases, psychosis disorders, or other medical history
- •Subjects with a past medical history of gastrointestinal disease or gastrointestinal surgeries
- •Pregnant subjects with a positive urine HCG test, or lactating female subjects
- •Subjects with hypersensitivity reactions or a clinically significant medical history of hypersensitivity reactions to drug substances and additives containing drug substances or other drugs
- •Subjects with clinically significant 12-lead ECG findings
- •Subjects with clinically significant laboratory test results as follows: Liver function test (AST, ALT, ALP, γ-GTP and total bilirubin), Creatinine, eGFR
- •Subjects with a past history of drug abuse or a positive urine drug test
- •Subjects with SBP ≥ 140 mmHg or ≤ 90 mmHg; DBP ≥ 90 mmHg or ≤ 60 mmHg; PR ≤ 50 beats/min or ≥ 100 beat/min
- •Subjects following an unusual diet or consumption of food which may affect the absorption, distribution, metabolism and excretion of the IP
- •Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals prior to the first IP administration
- •Subjects who have participated and were given any other study drugs in other clinical study within 6 months prior to the first IP administration
- •Subjects who have consistently drunk alcohol within 6 months
- •Subjects who have smoked more than 10 cigarettes/day on average
- •Subjects who have done and are unable to refrain from strenuous activity
- •Subjects who are planning for pregnancy or not willing to use a medically reliable forms of contraception
- •Subjects otherwise considered ineligible for participation due to other reasons including clinical laboratory test results not mentioned in the inclusion/exclusion criteria at the investigator's discretion
研究组 & 干预措施
Sequence A
Experimental
Period 1: Dapagliflozin and Sitagliptin / Period 2: SID1903 (FDC)
干预措施: SID1903 (FDC) (Drug)
Sequence A
Experimental
Period 1: Dapagliflozin and Sitagliptin / Period 2: SID1903 (FDC)
干预措施: Dapagliflozin and Sitagliptin (Drug)
Sequence B
Experimental
Period 1: SID1903 (FDC) / Period 2: Dapagliflozin and Sitagliptin
干预措施: SID1903 (FDC) (Drug)
Sequence B
Experimental
Period 1: SID1903 (FDC) / Period 2: Dapagliflozin and Sitagliptin
干预措施: Dapagliflozin and Sitagliptin (Drug)
结局指标
主要结局
AUC0-t
时间窗: up to 72 hours
Cmax
时间窗: up to 72 hours
次要结局
- Vd/F(up to 72 hours)
- AUCinf(up to 72 hours)
- λz(up to 72 hours)
- MRT(up to 72 hours)
- Tmax(up to 72 hours)
- t1/2(up to 72 hours)
- CL/F(up to 72 hours)
研究者
研究点 (1)
Loading locations...
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