None listed
Conditions
Interventions
Drug : Eligible subjects, determined on the basis of inclusion and exclusion criteria and baseline assessments on the first hospitalization day, were randomized into six sequence groups (n = 7 per seq
Sponsors
Korea United Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged over 19 (inclusive) at the time of screening. 2) Body weight =50 kg for males and =45 kg for females at the screening visit, with a body mass index (BMI) between 18 and 30 (BMI = weight (kg)/ height (m)2) 3) Subject with no clinically significant congenital or chronic diseases, and no pathological symptoms or abnormal findings on physical examination (if necessary, neurological examination, electroencephalogram, electrocardiogram (ECG), chest radiography, upper gastrointestinal endoscopy, or gastrointestinal radiologic examination). 4) Subject judged by investigators to be suitable for screening tests based on laboratory tests (e.g., blood tests, urine tests) and ECG, which were conducted according to the characteristics of the IP. 5) Subject who voluntarily signed the informed consent form after receiving a thorough explanation of the trial's purpose, content, characteristics of the investigational product, and potential adverse events. 6) Subject who had agreed to use medically appropriate contraceptive methods* (excluding hormonal contraceptives) to exclude the possibility of pregnancy for themselves or their spouse/partner from the first dose of the IP to 7 days after the last dose, and not to donate sperm or ovum. * medically appropriate contraceptive methods: Combination use of intrauterine device (IUD) or system (IUS), vasectomy, tubal ligation and barrier methods of contraception (male condoms, female condoms, cervical caps, contraceptive diaphragm, sponges, etc.) or the use of combined spermicide, involves the simultaneous use of two or more barrier methods
Exclusion criteria
Exclusion criteria: 1) Subject who have taken medications that strongly induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 30 days prior to the first IP administration, or medications that may affect this study within 10 days prior to the first IP administration. 2) Subject who have participated in another clinical trial (including bioequivalence studies) and received an IP within six months prior to the first IP administration. 3) Subject who have donated whole blood within eight weeks or component blood within two weeks prior to the first IP administration. 4) Subject with a history of gastrointestinal surgery that may affect IPs absorption (excluding simple appendectomy or hernia repair). 5) Subject with a history of regular alcohol consumption within 1 month prior to the fisrt IP administration. - An average of more than 21 units/week for males - An average of more than 14 units/week for females (1 unit = 50 mL soju, 250 mL beer, or 30 mL whisky) 6) Subject with the following conditions - Patients with known hypersensitivity to the active ingredient of the investigational product or any of its excipients. - Patients who have experienced phototoxic or photoallergic reactions during treatment with fibrates or ketoprofen. - Patients with active liver disease or persistent elevation of aminotransferases of unexplained origin. - Patients with gallbladder disease. - Patients with severe hepatic impairment, biliary obstruction, or cholestasis. - Patients with chronic or acute pancreatitis, except for acute pancreatitis associated with severe hypertriglyceridemia. - Patients with moderate to severe renal impairment (estimated glomerular filtration rate <60 mL/min/1.73m2). - Patients receiving ongoing treatment with fibrates, statins, or cyclosporine. - Patients with primary biliary cirrhosis. - Patients with myopathy; history of rhabdomyolysis or myopathy associated with statin or fibrate therapy; or history of creatine kinase (CK) elevation =5 times the upper limit of normal during prior statin therapy. - Patients with interstitial lung disease. - Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. - Patients with genetic disorders such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency. 7) Subjects with a history of clinically significant psychiatric disorders. 8) Subject determined by the principal investigator (or delegated sub-investigator) to be ineligible for participation in the clinical trial. 9) Subject who is pregnant, potentially pregnant, or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt of Fenofibric acid;Cmax of Fenofibric acid;AUCt of Pitavastatin;Cmax of Pitavastatin | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC8, Tmax, t1/2, ?z, Vd/F, CL/F of Fenofibric acid;AUC8, Tmax, t1/2, ?z, Vd/F, CL/F of Pitavastatin | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunjun Park
Bumin Hospital
Outcome results
None listed