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NCT05634447
A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391
Conditions: Dyslipidemias
Sex: All
Ages: 19 Years – 55 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 66
Sponsor: Chong Kun Dang Pharmaceutical
Location: Korea, Republic of
Summary
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-391
Eligibility Criteria
Inclusion Criteria:Healthy adult aged between 19 to 55 at screeningWeight ≥ 50kg(man) or 45kg(woman), with calculated body mass index (BMI) of 18 to 30kg/m2Those who have no clinically significant congenital or chronic diseases and have no abnormal symptoms of findingsThose who are deemed suitable for clinical trials based on laboratory (hematology, blood chemistry, serology, urinalysis, urine drug test) and 12-lead ECG results at screeningThose who agree to contraception from the first IP dosing day till 14 days after the last dosing day and decide not to provide sperm during the participation of clinical trialThose who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trialExclusion Criteria:Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing dayThose who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 21 glasses/week(man), 14 glasses/week(woman), smoking> 20 cigarettes/day) and not able to stop on smoking, caffeine and alcoholThose who received investigational products or participated in bioequivalence test within 6 months before the first administration of clinical trial drugsThose who donated whole blood within 8 weeks before the first date of administration and donated ingredients within 2 weeks or received blood transfusion in 4 weeksThose who have a history of gastrointestinal surgery except simple appendectomy and hernia surgeryPatients with the following diseasesPatients with active liver disease or with elevated amino transferase levels with unknown cause increased by more than 3 times the normal upper limitPatients with severe liver failure or biliary obstruction and bile congestionPatients with muscular disease, rhabdomyolysis, or persons with a past historyPatients with hypothyroidism, patients with genetic muscle disease or their family history, and patients with history of muscle disability due to drugsPatients with renal impairment or a history of in and patients with severe renal dysfunctionPatients with a history of muscle toxicity to other statin drugs or fibrate drugsThose who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorptionThose who have hypersensitivity to the main constituents or components of the investigational drugThose who have a history of drug abuse within 1 year of screening or who have tested positive for urine drug testsWoman who are pregnant or breastfeedingThose who are deemed insufficient to participate in clinical study by investigators
Source: ClinicalTrials.gov (NCT05634447). StuddyBuddy aggregates publicly available trial information.