KCT0012276进行中（未招募）不适用
An open-label, multiple-dose, crossover study to investigate the effect of herbal medication on the pharmacokinetics and safety of pregabalin following co-administration in healthy adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 19(Year) 至 55(Year)（—）
- 性别
- All
入选标准
- •Healthy adults aged 19 to 55 years at the time of screening.
- •Body weight =55 kg for males, and =50 kg for females.
- •Body mass index (BMI) =18.5 kg/m² and <27.0 kg/m².
- •? BMI (kg/m²) = weight (kg) / [height (m)]²
- •If female, must meet at least one of the following:
- •Postmenopausal (no natural menses for at least 2 years)
- •Surgically sterile (history of hysterectomy, bilateral oophorectomy, tubal ligation, or other methods leading to infertility)
- •If male and sexually active with a woman of childbearing potential, must agree to use acceptable contraception* and not donate sperm throughout the study and for at least 10 weeks after the last administration of the investigational medicinal product (IMP).
- •*Acceptable contraception methods include vasectomy, intrauterine device (IUD), tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge). If spermicides are used, at least two barrier methods must be combined.
- •Willing and able to provide written informed consent after receiving a full explanation of the study and agreeing to comply with all study requirements.
排除标准
- •History or presence of clinically significant diseases of the hepatobiliary system (e.g., severe hepatic impairment), renal system (e.g., severe renal impairment), cardiovascular system (e.g., uncontrolled hypertension, heart failure), immune system, nervous system (e.g., severe myasthenia), genitourinary system, gastrointestinal system, endocrine system, hematologic/oncologic disorders, or psychiatric disorders.
- •Lifetime history of suicide attempt, or suicidal ideation within 6 months prior to the first administration of the investigational medicinal product (IMP).
- •History of gastrointestinal disease (e.g., Crohn’s disease, ulcerative colitis) or surgery that may affect drug absorption (except simple appendectomy or hernia repair).
- •Known hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •History of clinically significant hypersensitivity to pregabalin or any excipients of the IMP.
- •History of drug dependence or abuse.
- •Any of the following laboratory or clinical findings at screening (within 28 days before first dosing) considered unsuitable for participation:
- •AST or ALT >1.5 × upper limit of normal (ULN)
- •Total bilirubin >1.5 × ULN
- •Creatine phosphokinase (CPK) >2.0 × ULN
- •eGFR <60 mL/min/1.73 m² (calculated by CKD-EPI formula)
- •Positive serology for hepatitis B, hepatitis C, or HIV
- •Sitting vital signs after =5 minutes rest: systolic BP >150 mmHg or <90 mmHg, diastolic BP >100 mmHg or <50 mmHg
- •Positive urine drug screening test
- •Use of medications (excluding topical agents without systemic absorption) that may affect study outcomes or subject safety, including:
- •Prescription drugs or herbal medicines within 14 days before first dosing
- •Over-the-counter medications, vitamins, or health supplements within 7 days before first dosing
- •Enzyme-inducing or enzyme-inhibiting drugs (e.g., barbiturates) within 30 days before first dosing
- •Habitual excessive use of tobacco, caffeine, or alcohol, or inability to abstain during each inpatient period:
- •Caffeine >5 cups/day
- •Alcohol >210 g/week
- •Tobacco >10 cigarettes/day
- •Consumption of grapefruit-containing foods within 7 days before first dosing or inability to abstain during the study period.
- •Participation in another clinical trial and exposure to an IMP within 180 days prior to first dosing (longer if required based on the half-life of a biologic agent).
- •Whole blood donation within 60 days or component blood donation within 30 days prior to first dosing.
- •Receipt of a blood transfusion within 30 days prior to first dosing.
- •Pregnant or breastfeeding women.
- •Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.
研究者
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