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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06292091
Other study ID # Ur_ABD_PK
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 28, 2024
Est. completion date April 1, 2024

Study information

Verified date April 2024
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

- Pharmacokinetic analysis of captopril before and after urine acid-base imbalance - Safety analysis


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 1, 2024
Est. primary completion date March 27, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 50 Years
Eligibility 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 other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity reactions - Participants with genetic problems such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption - Positive serum test (HBs antigen, HCV antibody, HIV antigen-antibody, and RPR) at screening - Past history of alcohol and drug abuse or a positive urine test for drugs with abuse potential at screening - 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 - QT/QTcF > 450 msec or any abnormalities on electrocardiogram (ECG) at screening - Any abnormalities in blood tests at screening - AST (SGOT), ALT (SGPT) > 60 IU/L, creatinine clearance (CKD-EPI equation) < 80 mL/min - 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). - 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 - Treatment with any investigational product in another clinical trial within 6 months prior to the first scheduled dose

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Captopril 12.5 Mg
12.5 mg of captopril
Sodium bicarbonate 4 G
4 g of sodium bicarbonate
Torsemide 20 MG
20 mg of torsemide

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUClast of captopril Area under the concentration-time curve from 0 to last measurable concentration (AUClast) Pre-dose (0 hour) and up to 12 hours in each period
Primary Cmax of captopril Maximum concentration of captopril (Cmax) Observed value among pre-dose (0 hour) and up to 12 hours in each period
Secondary AUCinf of captopril Area under the concentration-time curve from 0 to infinite (AUCinf) Pre-dose (0 hour) and up to 12 hours in each period
Secondary Tmax of captopril Time to Cmax (Tmax) Observed time point among pre-dose (0 hour) and up to 12 hours in each period
Secondary t1/2 of captopril half-life (t1/2) Pre-dose (0 hour) and up to 12 hours in each period
Secondary CL/F of captopril Apparent clearance (CL/F) Pre-dose (0 hour) and up to 12 hours in each period
Secondary Vd/F of captopril Apparent volume of distribution (Vd/F) Pre-dose (0 hour) and up to 12 hours in each period
Secondary fe of captopril Fraction of urinary excretion (fe) Pre-dose (0 hour) and up to 12 hours in each period
Secondary urine pH urine pH Pre-dose (0 hour) and up to 12 hours in each period
Secondary Safety parameters Number and frequency of participants observed adverse events in each period Through study completion, an average of 3 months
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