HypertensionPhase 1NCT06292091
A Study to Investigate the Effect of Urine Acid-base Disequilibrium on the Pharmacokinetics of Captopril
A Phase 1 study testing Captopril 12.5 Mg, Sodium bicarbonate 4 G and Torsemide 20 MG in people with Hypertension, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Captopril 12.5 Mg, Sodium bicarbonate 4 G and Torsemide 20 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Feb 2024to 1 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The aim of this study is to evaluate the effect of urine acid-base disequilibrium on the pharmacokinetics of captopril in healthy male volunteers.
Read the detailed description
- Pharmacokinetic analysis of captopril before and after urine acid-base imbalance
- Safety analysis
- Conditions
- Hypertension
- Being tested
- Captopril 12.5 Mg, Sodium bicarbonate 4 G, Torsemide 20 MG
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Captopril 12.5 MgDrug
12.5 mg of captopril
Sodium bicarbonate 4 GDrug
4 g of sodium bicarbonate
Torsemide 20 MGDrug
20 mg of torsemide
| Study group | Role | What they receive |
|---|---|---|
| Captopril | Active comparator | Single dose of captopril 12.5 mg Receives: Drug: Captopril 12.5 Mg |
| Sodium bicarbonate+captopril | Experimental | Single dose of captopril 12.5 mg during multiple doses of sodium bicarbonate 1 g every 4-6 hours Receives: Drug: Captopril 12.5 Mg; Drug: Sodium bicarbonate 4 G |
| Torsemide+captopril | Experimental | Single dose of captopril 12.5 mg during multiple doses of torsemide 20 mg every 6-12 hours Receives: Drug: Captopril 12.5 Mg; Drug: Torsemide 20 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of captopril
Area under the concentration-time curve from 0 to last measurable concentration (AUClast)
Measured: Pre-dose (0 hour) and up to 12 hours in each period
Cmax of captopril
Maximum concentration of captopril (Cmax)
Measured: Observed value among pre-dose (0 hour) and up to 12 hours in each period
Secondary outcomes (8)
AUCinf of captopril
Area under the concentration-time curve from 0 to infinite (AUCinf)
Measured: Pre-dose (0 hour) and up to 12 hours in each period
Tmax of captopril
Time to Cmax (Tmax)
Measured: Observed time point among pre-dose (0 hour) and up to 12 hours in each period
t1/2 of captopril
half-life (t1/2)
Measured: Pre-dose (0 hour) and up to 12 hours in each period
CL/F of captopril
Apparent clearance (CL/F)
Measured: Pre-dose (0 hour) and up to 12 hours in each period
Vd/F of captopril
Apparent volume of distribution (Vd/F)
Measured: Pre-dose (0 hour) and up to 12 hours in each period
fe of captopril
Fraction of urinary excretion (fe)
Measured: Pre-dose (0 hour) and up to 12 hours in each period
urine pH
urine pH
Measured: Pre-dose (0 hour) and up to 12 hours in each period
Safety parameters
Number and frequency of participants observed adverse events in each period
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start28 Feb 2024
- Primary completion27 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SeungHwan Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292091
- Sponsor's protocol ID
- Ur_ABD_PK
- Status last verified
- Apr 2024
- First submitted
- 13 Feb 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06292091
- Acronym / sponsor ID
- Ur_ABD_PK
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Captopril | Active comparator | Drug: Captopril 12.5 MgSingle dose of captopril 12.5 mg |
| Sodium bicarbonate+captopril | Experimental | Drug: Captopril 12.5 Mg, Drug: Sodium bicarbonate 4 GSingle dose of captopril 12.5 mg during multiple doses of sodium bicarbonate 1 g every 4-6 hours |
| Torsemide+captopril | Experimental | Drug: Captopril 12.5 Mg, Drug: Torsemide 20 MGSingle dose of captopril 12.5 mg during multiple doses of torsemide 20 mg every 6-12 hours |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Captopril 12.5 Mg12.5 mg of captopril | Drug | Captopril, Sodium bicarbonate+captopril, Torsemide+captopril |
| Sodium bicarbonate 4 G4 g of sodium bicarbonate | Drug | Sodium bicarbonate+captopril |
| Torsemide 20 MG20 mg of torsemide | Drug | Torsemide+captopril |
Primary outcome
AUClast of captopril
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
Area under the concentration-time curve from 0 to last measurable concentration (AUClast)
Cmax of captopril
Time frame: Observed value among pre-dose (0 hour) and up to 12 hours in each period
Maximum concentration of captopril (Cmax)
8 secondary outcomes
AUCinf of captopril
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
Tmax of captopril
Time frame: Observed time point among pre-dose (0 hour) and up to 12 hours in each period
t1/2 of captopril
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
CL/F of captopril
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
Vd/F of captopril
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
fe of captopril
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
urine pH
Time frame: Pre-dose (0 hour) and up to 12 hours in each period
Safety parameters
Time frame: Through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Captopril 12.5 Mg, Sodium bicarbonate 4 G and Torsemide 20 MG in people with Hypertension, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUClast of captopril (time frame: Pre-dose (0 hour) and up to 12 hours in each period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.