KCT0009261招募中Unknown
An open-label, fixed-sequence, 3-period crossover exploratory study to investigate the effect of urine acid-base disequilibrium on the pharmacokinetics of captopril in healthy male volunteers
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 50(Year)（—）
- 性别
- Male
入选标准
- •1) Healthy male volunteer aged 19 to 50 years at screening
- •2) Body weight between 50.0 kg and 90.0 kg and body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at screening
- •- Body Mass Index (kg/m2) = Weight (kg)/{Height (m)}2
- •3) Participants who voluntarily decided to participate and agreed in writing to comply with study instructions after receiving sufficient explanation and complete understanding of the study
- •4) Participants who are suitable as test subjects for this test as determined by the investigator through physical examination, clinical laboratory tests, and interviews, etc.
排除标准
- •1) Participants who have or have a history of clinically significant hepatobiliary system (severe liver failure, viral hepatitis, etc.), kidney (severe renal impairment, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood/tumor, cardiovascular system (heart failure, Torsades de pointes, etc.), urinary system, mental system (mood disorder, obsessive-compulsive disorder, etc.), and sexual dysfunction, etc.
- •2) Evidence or past history of gastrointestinal disease (Crohn’s disease, gastrointestinal ulcer, gastritis, gastroesophageal reflux disease, etc.) or past history of gastrointestinal surgery (except for simple appendectomy and hernia repair) that might affect the safety and PK assessment of the investigational product .
- •3) Hypersensitivity to drugs including captopril, sodium bicarbonate, and torsemide or other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity reactions
- •4) Participants with genetic problems such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •5) Positive serum test (HBs antigen, HCV antibody, HIV antigen-antibody, and RPR) at screening
- •6) Past history of alcohol and drug abuse or a positive urine test for drugs with abuse potential at screening
- •7) Any abnormalities in vital signs after 3 minutes rest at screening
- •- Systolic blood pressure < 90 mmHg or > 150 mmHg, Diastolic blood pressure < 60 mmHg or > 100 mHg
- •8) QT/QTcF > 450 msec or any abnormalities on electrocardiogram (ECG) at screening
- •9) Any abnormalities in blood tests at screening
- •- AST (SGOT), ALT (SGPT) > 60 IU/L, creatinine clearance (CKD-EPI equation) : < 80 mL/min
- •10) Past or planned treatment with any prescription drugs or herbal medicine within 2 weeks, or any over the counter drugs, health functional foods, or vitamin supplements within 1 week, prior to the first scheduled dose (individual who is eligible based on other criteria may participate in the study at the discretion of the
- •investigator).
- •11) Participants who have taken drugs that induce drug-metabolizing enzymes such as barbiturates or inhibit drug metabolism such as clarithromycin within 1 month prior to the first scheduled dose
- •12) Treatment with any IP in another clinical trial within 6 months prior to the first scheduled dose
研究者
相似试验
进行中（未招募）
1 期
Relative bioavailability study of marketed and lower dose ambrisentan in healthy adult participantsPulmonary arterial hypertensionEUCTR2019-001699-12-GBGlaxoSmithKline Research and Development Ltd24
已完成
不适用
An open*label, randomized, 3*period crossover study to determine the relative bioavailability of ASN120290 from a film*coated tablet given under fasted and fed conditions as compared to a capsule given under fasted conditions in healthy subjectsPSPNL-OMON48189Asceneuron SA15
进行中（未招募）
1 期
Study to compare the pharmacokinetics of mometasone furoate alone and in combination with indacaterol in patients = 6 to < 12 years old with asthmaAsthma in pediatric patientsMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2020-002036-78-HUovartis Pharma AG32
进行中（未招募）
1 期
A study to assess the effect of itraconazole and phenytoin on BIIB113 and the effect of BIIB113 on midazolam in healthy participantsISRCTN48011192Biogen (United Kingdom)70
进行中（未招募）
1 期
An open label, randomized, three-period, three-sequence, crossover bioavailability study to assess the pharmacokinetic and safety profile of Valacyclovir Oral Suspension compared to Valtrex® extemporaneous suspension in normal, healthy subjects under fasting conditions and to investigate the effect of food on the bioavailability of Valacyclovir Oral Suspension.ot applicable (submitted trial is a bioequivalence study in healthy subjects)MedDRA version: 20.0Level: HLGTClassification code: 10047438Term: Viral infectious disorders Class: 10021881CTIS2023-504760-42-00Dermax30