None listed
Conditions
Interventions
Drug : This clinical trial will be conducted as an open-label, randomized, single-dose, two-arm, parallel study.
All study participants will receive a single oral dose of either the investigational dr
Sponsors
Addpharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals aged between 19 and 55 years at the time of the screening visit. 2) Individuals 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 at the time of the screening visit. ? BMI (kg/m²) = Weight (kg) / {Height (m)}² 3) Individuals with no clinically significant congenital or chronic diseases and no abnormal findings based on medical history and physical examination during the screening visit. 4) Individuals deemed suitable as study subjects based on diagnostic tests (hematology, blood chemistry, serology, urinalysis, etc.) and electrocardiogram (ECG) results performed according to the characteristics of the investigational product, as determined by the principal investigator (or delegated study physician). 5) Individuals who agree to use medically recognized contraception methods* (excluding hormonal contraceptives) and agree not to donate sperm or eggs to eliminate the possibility of pregnancy for themselves, their spouse, or partner until 21 days after investigational drug administration. *Medically recognized contraception methods: Use of an intrauterine device, vasectomy, tubal ligation, or barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.), or the combined use of two or more barrier methods with spermicides. 6) Individuals who have been fully informed about the purpose, content, characteristics of the investigational drug, and potential adverse events of the clinical trial, and who voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Individuals with clinically significant diseases or histories in the following systems: gastrointestinal, cardiovascular, endocrine, respiratory, hematologic/oncologic, infectious diseases, renal and genitourinary, psychiatric/neurological, musculoskeletal, immune, otolaryngological, dermatological, and ophthalmological systems. 2) Individuals with a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia repair) or those with gastrointestinal disorders. 3) Individuals who have taken enzyme-inducing or enzyme-inhibiting drugs, such as barbiturates, within one month before the dosing date or any medications likely to interfere with this clinical trial within 10 days before the dosing date (participation may be allowed if there are no concerns about interactions, half-life, or pharmacokinetics/pharmacodynamics of the investigational drug). 4) Individuals who participated in another clinical trial or bioequivalence study and received investigational drugs within 6 months prior to the dosing date. 5) Individuals who donated whole blood within 8 weeks, donated blood components within 2 weeks, or received a blood transfusion within 4 weeks prior to the dosing date. 6) Individuals meeting the following conditions within 1 month prior to the dosing date: · For males: average alcohol consumption exceeding 21 drinks/week. · For females: average alcohol consumption exceeding 14 drinks/week. (1 drink = 50 mL of soju, 30 mL of whiskey, or 250 mL of beer). · Smoking more than an average of 20 cigarettes/day. 7) Individuals with: · Hypersensitivity or a history of hypersensitivity to this drug, its components, dihydropyridine derivatives, thiazide diuretics, or sulfonamide drugs. · Genetic issues causing intolerance or other adverse reactions to the excipients of this drug. 8) Patients with the following conditions: · Biliary obstruction. · Severe hepatic impairment. · Severe aortic valve stenosis. · Severe hypotension (systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg). · Shock. · Diabetes or moderate to severe renal impairment (glomerular filtration rate <60 mL/min/1.73 m²). · Anuria. · Severe renal failure. · Refractory hypokalemia. · Hyponatremia or hypercalcemia. · Symptomatic hyperuricemia (history of gout or urate nephrolithiasis). · Untreated Addison’s disease. · Undergoing lithium therapy. · Receiving terfenadine or astemizole. 9) Individuals deemed unsuitable for participation in this clinical trial for any reason other than the inclusion/exclusion criteria above, as determined by the principal investigator (or delegated study physician). 10) For female volunteers: those who are pregnant, suspected of being pregnant, or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Telmisartan, Amlodipine, Chlorthalidone AUCt, Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| Telmisartan, Amlodipine, Chlorthalidone AUC8, Tmax, t1/2, AUCt/AUC8, CL/F, Vd/F | — |
Countries
Korea, Republic of
Contacts
Public ContactSEUNGHYUN KANG
H Plus Yangji Hospital
Outcome results
None listed