None listed
Conditions
Sponsors
Addpharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects aged 19 years or older at the time of the screening visit. 2) Subjects with a body weight of at least 50 kg (at least 45 kg for females) and a body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m², inclusive, at the screening visit. ? BMI (kg/m²) = body weight (kg) / [height (m)]² 3) Subjects with no clinically significant congenital or chronic diseases and no pathological symptoms or findings on internal medicine examination at the screening visit. 4) Subjects whose sitting blood pressure, measured after sufficient rest at the screening visit, satisfies all of the following criteria: · Systolic blood pressure: 90–139 mmHg · Diastolic blood pressure: 60–89 mmHg 5) Subjects judged to be eligible for participation based on the results of diagnostic tests—such as hematology, blood chemistry, serology, urinalysis—and electrocardiography, as determined by the principal investigator (or a delegated sub-investigator) in accordance with the characteristics of the investigational product. 6) Subjects who agree to exclude the possibility of pregnancy by using a medically acceptable method of contraception* (excluding hormonal methods) by themselves or their spouse/partner from the first administration of the investigational product until 21 days after the last administration, and who agree not to donate sperm or ova during this period. * Medically acceptable methods of contraception include: intrauterine devices (IUDs), vasectomy, tubal ligation, and barrier methods (male condoms, female condoms, cervical caps, diaphragms, sponges, etc.) used in combination, or the combined use of two or more barrier methods when spermicides are used. 7) Subjects who have received and fully understood sufficient explanation of the purpose and details of this clinical trial, the characteristics of the investigational product, and the expected adverse events, and who have voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Subjects with clinically significant diseases or a history thereof involving the gastrointestinal, cardiovascular, endocrine, respiratory, hematologic/oncologic, infectious, renal and genitourinary, psychiatric/neurologic, musculoskeletal, immune, otorhinolaryngologic, dermatologic, or ophthalmologic systems. 2) Subjects with a history of gastrointestinal surgery that may affect drug absorption (excluding simple appendectomy or hernia repair), or those with gastrointestinal diseases that may influence drug absorption. 3) Subjects who have taken enzyme-inducing or enzyme-inhibiting drugs (e.g., barbiturates) within 1 month prior to the first dosing, or who have taken any medications that may interfere with this clinical trial within 10 days prior to the first dosing; however, participation may be allowed based on pharmacokinetic and pharmacodynamic considerations, including drug–drug interactions and half-life, of the investigational product. 4) Subjects who have participated in another clinical trial or bioequivalence study and received an investigational product within 6 months prior to the first dosing. 5) Subjects who have donated whole blood within 8 weeks, donated blood components within 2 weeks, or received a blood transfusion within 4 weeks prior to the first dosing. 6) Subjects who meet any of the following conditions within 1 month prior to the first dosing: · Alcohol consumption exceeding an average of 21 standard drinks per week for males · Alcohol consumption exceeding an average of 14 standard drinks per week for females (1 standard drink = 50 mL of soju, 30 mL of spirits, or 250 mL of beer) · Smoking more than an average of 20 cigarettes per day 7) Subjects with any of the following conditions: · Severe hepatic impairment · Biliary obstruction or cholestasis · Hereditary angioedema, or a history of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists · Diabetes mellitus or moderate to severe renal impairment (eGFR < 60 mL/min/1.73 m²) · Anuria · Hypersensitivity or a history of hypersensitivity to this drug, any of its components, thiazide diuretics, or other sulfonamide derivatives · Refractory hypokalemia · Hyponatremia or hypercalcemia · Symptomatic hyperuricemia (history of gout or uric acid nephrolithiasis) · Untreated Addison’s disease · Ongoing lithium therapy · Concomitant use of terfenadine or astemizole · Hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 8) Subjects deemed unsuitable for participation in this clinical trial by the principal investigator (or a delegated sub-investigator) for any reason other than those listed above. 9) Female subjects who are pregnant, suspected to be pregnant, or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the blood concentration–time curve from dosing to the final quantifiable sampling time t (AUCt);Maximum concentration of drug in plasma (Cmax) | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma drug concentration-time curve from time 0 to infinity (AUC8);Time to maximum plasma concentration (Tmax);the ratio of the area under the blood concentration–time curve from dosing to the last quantifiable time t to that extrapolated to infinity (AUCt/AUC8);Terminal elimination half-life (t1/2) | — |
Countries
Korea, Republic of
Contacts
Public ContactSEUNGHYUN KANG
H Plus Yangji Hospital
Outcome results
None listed