A Study to Investigate the Effect of Urine Acid-base Disequilibrium on the Pharmacokinetics of Ca… (NCT06292091) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Effect of Urine Acid-base Disequilibrium on the Pharmacokinetics of Captopril
South Korea12 participantsStarted 2024-02-28
Plain-language summary
The aim of this study is to evaluate the effect of urine acid-base disequilibrium on the pharmacokinetics of captopril in healthy male volunteers.
Who can participate
Age range19 Years – 50 Years
SexMALE
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Inclusion Criteria:
* Healthy male volunteer aged 19 to 50 years at screening
* 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
* 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
* 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:
* 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.
* 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.
* Hypersensitivity to drugs including captopril, sodium bicarbonate, and torsemide or o…
What they're measuring
1
AUClast of captopril
Timeframe: Pre-dose (0 hour) and up to 12 hours in each period
2
Cmax of captopril
Timeframe: Observed value among pre-dose (0 hour) and up to 12 hours in each period