NCT07691268已完成1 期
Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of "UI111" and "UIC202006" in Healthy Adult Volunteers Under Fed State Conditions
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- AUCt
研究概览
简要总结
Phase 1 study to evaluate the safety and the pharmacokinetics of "UI111" and "UIC202006" in healthy adult volunteers under fed state conditions
- Open-label, randomized, single-dose, 2-sequence, 4-period, crossover design
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are at least 19 years of age at the time of the screening visit.
- •Subjects who weigh at least 50 kg (at least 45 kg for females) and have a body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive, at the time of the screening visit. ☞ BMI (kg/m²) = body weight (kg) / [height (m)]²
- •Subjects who have no clinically significant congenital or chronic diseases and no pathological symptoms or findings based on the medical examination at the time of the screening visit.
- •Subjects who are determined to be eligible for participation in the study by the Principal Investigator (or a delegated sub-investigator) based on the results of diagnostic assessments, including hematology, blood chemistry, serology, urinalysis, electrocardiogram (ECG), and any other evaluations performed according to the characteristics of the investigational product.
- •Subjects who agree that they and/or their spouse or partner will use medically acceptable contraceptive methods (excluding hormonal contraceptives) from the first administration of the investigational product until 7 days after the last administration of the investigational product to prevent pregnancy, and who agree not to donate sperm or ova during this period.*
- •Medically acceptable contraceptive methods include an intrauterine device (IUD), vasectomy, tubal ligation, or the combined use of barrier methods (e.g., male condom, female condom, cervical cap, diaphragm, or contraceptive sponge). If spermicide is used, it must be combined with at least two barrier methods.
- •Subjects who have received and understood a full explanation of the purpose and procedures of the study, the characteristics of the investigational product, and the anticipated adverse events, and who voluntarily provide written informed consent prior to participation in the study.
排除标准
- •Subjects who have a current or past history of clinically significant diseases involving the gastrointestinal, cardiovascular, endocrine, respiratory, hematologic/oncologic, infectious, renal and genitourinary, psychiatric, neurological, musculoskeletal, immune, otorhinolaryngological (ear, nose, and throat), dermatologic, or ophthalmologic systems.
- •Subjects with a history of gastrointestinal surgery that may affect drug absorption (except for uncomplicated appendectomy or hernia repair), or with current gastrointestinal diseases that may affect drug absorption.
- •Subjects who have taken medications known to induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 1 month prior to the first administration of the investigational product, or any medication that may interfere with the conduct of this study within 10 days prior to the first administration of the investigational product. However, participation may be permitted after consideration of the pharmacokinetic and pharmacodynamic characteristics of the medication, including its potential interaction with the investigational product and elimination half-life.
- •Subjects who have participated in another clinical trial or bioequivalence study and received an investigational product within 6 months prior to the first administration of the investigational product in this study.
- •Subjects who have donated whole blood within 8 weeks, donated blood components (e.g., platelet or plasma donation) within 2 weeks, or received a blood transfusion within 4 weeks prior to the first administration of the investigational product.
- •Subjects who, within 1 month prior to the first administration of the investigational product, meet any of the following criteria:
- •For males: average alcohol consumption exceeding 21 standard drinks per week. For females: average alcohol consumption exceeding 14 standard drinks per week. (One standard drink = 50 mL of soju, 30 mL of spirits, or 250 mL of beer.) Smoking more than an average of 20 cigarettes per day. - Subjects who meet any of the following criteria: Known hypersensitivity to the investigational product or any of its components. Hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •- Subjects with any of the following conditions: Severe hepatic impairment (e.g., biliary cirrhosis, active liver disease, or persistent unexplained elevations of transaminases exceeding 3 × the upper limit of normal [ULN]).
- •Moderate to severe renal impairment (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m²).
- •A history of photoallergic or phototoxic reactions during treatment with fibrates or ketoprofen.
- •Gallbladder disease. Acute or chronic pancreatitis associated with hypertriglyceridemia. Myopathy; a history of rhabdomyolysis or myopathy associated with statins or fibrates; or a history of creatine phosphokinase (CPK) elevations ≥5 × ULN during previous statin therapy.
- •Interstitial lung disease. A history of pulmonary embolism. Severe myasthenia gravis or ocular myasthenia.
- •Subjects whom the Principal Investigator (or a delegated sub-investigator) considers unsuitable for participation in this study for any reason other than the inclusion and exclusion criteria listed above.
- •Female subjects who are pregnant, suspected to be pregnant, or breastfeeding.
结局指标
主要结局
AUCt
时间窗: 0 to 12hours(Active ingredient A), 0 to 72hours(Active ingredient B)
Cmax
时间窗: 0 to 12hours(Active ingredient A), 0 to 72hours(Active ingredient B)
次要结局
未报告次要终点
研究者
研究点 (1)
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