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A Study to Investigate the Effect of Urine Acid-base Disequilibrium on the Pharmacokinetics of Captopril | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Investigate the Effect of Urine Acid-base Disequilibrium on the Pharmacokinetics of Captopril

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

NCT06292091•Seoul National University Hospital

View on ClinicalTrials.gov

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.

Detailed Description

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

Eligibility

Age

19 - 50 years

Sex

MALE

Healthy Volunteers

Yes

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
+4 more criteria

Locations (1)

Seoul National University Hospital

Seoul, Seoul, South Korea

Key Dates

Start Date

February 28, 2024

Primary Completion Date

March 27, 2024

Completion Date

April 1, 2024

Last Updated

May 30, 2025

Enrollment

ACTUAL participants

Conditions

Hypertension

Interventions

Captopril 12.5 Mg

DRUG

Sodium bicarbonate 4 G

DRUG

Torsemide 20 MG

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Investigate the Effect of Urine Acid-base Disequilibrium on the Pharmacokinetics of Captopril

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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