None listed
Conditions
Interventions
Drug : This clinical trial is conducted in open-label, randomized, single-dose, 2-sequence, 4-period and repeated-crossover.
All subjects will experience the test drug(AD-207 single dose) and the ref
Sponsors
Addpharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person who is 19 years of age or older at the time of a screening visit 2) A person who has no birth or chronic disease based on screening and has no medical examination results (e.g., electrocardiogram, chest and gastroscopy or gastrointestinal radiography if necessary) or no pathological symptoms or findings 3) A person who is deemed suitable as a test subject as a result of clinical laboratory tests (hematology tests, blood chemistry tests, urine tests, etc.) and electrocardiogram tests (EKG) established and conducted by a person in charge of testing (or a delegated doctor in charge of testing) according to the characteristics of clinical trials 4) those with the following blood pressure ·Systolic blood pressure not less than 90 mmHg but not more than 139 mmHg ·The diastolic blood pressure is greater than or equal to 60 mmHg and less than or equal to 89 mmHg 5) A person whose BMI measurement results are greater than or equal to 18kg/m2 and less than or equal to 30kg/m2 at the time of a screening visit ·BMI (kg/m2) = Weight (kg) / Height (m) 2 6) Those who have no history of gastrointestinal diseases or gastrointestinal resection that can affect the absorption of clinical trial drugs 7) A person who has no history of mental illness within five years prior to the date of the screening visit 8) In the case of a female test subject, a person who is confirmed not to be pregnant at the time of a medical examination 9) A person who has signed a consent form according to his/her free will after hearing and understanding the purpose, contents, characteristics of the drug, expected adverse reactions, etc. of this test
Exclusion criteria
Exclusion criteria: 1) A person who has taken drug metabolite-inducing and inhibiting drugs such as barbiturant drugs within 30 days prior to the date of the screening visit 2) Drug users who are likely to interfere with testing within 10 days prior to a screening visit 3) Excessive alcohol drinkers within 30 days prior to the date of the screening visit ·More than 14 cups/week for women ·More than 21 cups/week for men (1 glass = 50mL of soju or 30mL of spirits or 250mL of beer) 4) Excessive smokers within 30 days prior to the date of the screening visit (over 20 cigarettes/day) 5) A person who has participated in other clinical trials or biological equivalence trials within six months prior to the first dose of a clinical trial drug 6) A person who has donated whole blood or donated ingredients within 14 days or received a blood transfusion within 30 days before the first dose of clinical trial drugs 7) A person who has a history of hypersensitivity to the main component (or dihydropyridine-based derivative) or components of clinical trial drugs or other drugs or additives, etc 8) A person who is not qualified for participation in this clinical trial by a person in charge of the trial (or a delegated test doctor) 9) Those whose blood AST (GOT) or ALT (GPT) levels exceed twice the upper limit of the reference range or whose ?-GTP levels exceed 1.5 times the upper limit of the reference range 10) A nursing mother 11) A patient with severe liver disorder or a person with biliary obstructive disease 12) a patient with severe aortic stenosis 13) Shock patient 14) People with muscle disease 15) Patients administered in combination with cyclosporine 16) Patients with renal impairment with moderate to severe renal failure 17) Patients prone to myopathy/rhabdomyolysis 18) Those with hypothyroidism 19) Those whose blood TSH level exceeds 5.50 µIU/mL 20) A person who has a history of genetic muscle disease or a family history 21) Those with a history of muscle toxicity to other HMG-CoA converting enzyme inhibitors or fibrate-based drugs 22) A person who is an alcoholic 23) A person on combination administration of fibrate-based drugs 24) Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption because this drug contains lactose 25) This drug contains sorbitol and therefore is genetically fructose intolerant 26) A person who does not agree to medically exclude the possibility of pregnancy by using contraception* by himself, his/her spouse, or his/her partner from the date of first administration of the clinical trial drug until 21 days after the date of last administration of the clinical trial drug * Contraception: Use a combination of intrauterine devices (IUD, IUS), vasectomy, oviduct ligation and blocking contraception (male condom, female condom, cervical cap, contraceptive septum, sponge, etc.), or use a combination of two or more blocking contraception when using a fertilizer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t, Cmax of Free Ezetimibe, Rosuvastatin, Telmisartan, Amlodipine | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-t, Cmax of Total Ezetimibe;AUCinf, Tmax, t1/2, AUC0-t/AUCinf of Rosuvastatin, Total Ezetimibe, Free Ezetimibe, Telmisartan, Amlodipine | — |
Countries
Korea, Republic of
Contacts
Public ContactSEUNGHYUN KANG
H Plus Yangji Hospital
Outcome results
None listed