None listed
Conditions
Interventions
Drug : This clinical trial is conducted in open-label, randomized, single-dose, 2-sequence, 4-period and crossover.
All subjects will experience the test drug(AD-218(Atorvastatin 20 mg/ Fenofibrate 1
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 the screening visit 2) A person who weighs 50 kg or more (women weigh more than 45 kg) and has a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less during a screening visit ? BMI (kg/m2) = Weight (kg)/{Height (m)}2 3) A person who does not have clinically meaningful congenital or chronic diseases at the time of a screening visit and has no pathological symptoms or findings as a result of medical examination 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) From the date of the first dose of the clinical trial drug to the 14th day after the date of the last clinical trial drug, either you or your spouse agrees to exclude the possibility of pregnancy using medically appropriate contraception* and to not provide sperm or eggs *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: • Patients who are hypersensitivity to this drug and its components • Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 8) Patients with the following conditions: • Patients with active liver disease or patients with elevated serum aminotransferase levels more than three times the normal upper limit • Patients with muscle disease (patients with CPK rise more than three times the normal upper limit) • Patients on Glecaprevir and Fibrentasvir • Patients with a liver disorder • Patients with moderate to severe renal impairment (serum creatinine level greater than 2.5 mg/dL) (Rhabdomyolysis may occur) • Patients with renal impairment (more than 1.20 mg/dL of creatinine, less than 60 ml/min/1.73 m² of eGFR) (Rhabdomyolysis may occur) • Patients with pre-existing gallbladder disease (cholelithiasis has been reported) • Patients who have experienced photoallergy or phototoxicity during treatment with fibrate or ketoprofen • Patients with bile duct cirrhosis • Patients with pancreatitis 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 |
|---|---|
| Atorvastatin AUCt, Cmax;Fenofibric Acid AUCt, Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| Atorvastatin AUC8, Tmax, t1/2, AUCt/AUC8;Fenofibric Acid AUC8, Tmax, t1/2, AUCt/AUC8;2-OH Atorvastatin AUCt, Cmax, AUC8, Tmax, t1/2, AUCt/AUC8 | — |
Countries
Korea, Republic of
Contacts
Public ContactJaewoo Kim
H Plus Yangji Hospital
Outcome results
None listed