Hypertension and Dyslipidemia
Conditions
Brief summary
A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348
Detailed description
An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-348 with coadministration of CKD-828, D097 and D337 in healthy adult volunteers
Interventions
DRUGCKD-348
QD, PO
QD, PO
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult volunteers aged ≥ 19 years 2. Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2 3. Those who meet the blood pressure criteria during screening tests: * Systolic Blood Pressure: 90 to 139 mmHg * Diastolic Blood Pressure: 60 to 89 mmHg 4. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings. 5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening. 6. Those who agree to contraception during the participation of clinical trial. 7. 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
1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs. 2. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products. 3. Those who donated whole blood or apheresis within 2 months or 1 month respectfully, or received blood transfusion within a month. 4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery. 5. Those who exceed an alcohol and cigarette consumption than below criteria * Alcohol: Man\_21 glasses/week, Woman\_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) * Smoking: 20 cigarettes/day 6. Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism. 7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption. 8. Those who are deemed insufficient to participate in this clinical study by investigators. 9. Woman who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt of CKD-348 | Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | AUCt: Area under the concentration-time curve from time zero to time |
| Cmax of CKD-348 | Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | Cmax: Maximum plasma concentration of the drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf of CKD-348 | Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | AUCinf: Area under the concentration-time curve from zero up to ∞ |
| Tmax of CKD-348 | Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | Tmax: Time to maximum plasma concentration |
| AUCt/AUCinf of CKD-348 | Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | AUCt/AUCinf |
| T1/2 of CKD-348 | Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | T1/2: Terminal elimination half-life |
Countries
South Korea
Outcome results
None listed