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Not Yet Recruiting NCT05698043

A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(5) 80/20/10mg

Conditions: Hypertension and Dyslipidemia

Sex: All
Ages: 19 Years – N/A
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 60
Sponsor: Chong Kun Dang Pharmaceutical

Location: Korea, Republic of

Summary

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-386(5)

Eligibility Criteria

Inclusion Criteria:Healthy adult volunteers aged ≥ 19 yearsWeight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2Those who meet the blood pressure criteria during screening tests:Systolic Blood Pressure: 90 to 139 mmHgDiastolic Blood Pressure: 60 to 89 mmHgThose who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.Those who agree to contraception during the participation of clinical trial.Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.Exclusion Criteria:Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.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 day (However, clinical investigational drugs) Participation is possible in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs)Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a 4 weeks.Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.Those who exceed an alcohol and cigarette consumption than below criteriaAlcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)Heavy Smoking: 20 cigarettes/dayPatients with the following diseasesPatients with hypersensitivity to the main constituents or components of the investigational drugSevere hepatic impairment, biliary atresia or cholestasisPatients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonistsDiabetes mellitusPatients with moderate to severe renal impairment [glomerular filtration rate (eGFR) <60 mL / min / 1.73m^2]Renal vascular hypertension patientsPatients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limitPatients with myopathy or have a history of family or genetic history of myopathyHypothyroidismIf you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugsThose who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.Those who are deemed insufficient to participate in this clinical study by investigators.Woman who are pregnant or breastfeeding.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05698043). StuddyBuddy aggregates publicly available trial information.