KCT0009261
Recruiting
未知
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
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Seoul National University Hospital
- Enrollment
- 12
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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