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A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348(2)
An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-348(2) with coadministration of CKD-828, D097 and D337 in healthy adult volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(2) - A single oral dose of 1 tablet under fasting condition Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 4: CKD-348(2) - A single oral dose of 1 tablet under fasting condition |
|
| Sequence 2 | Experimental | Period 1: CKD-348(2) - A single oral dose of 1 tablet under fasting condition Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-348(2) - A single oral dose of 1 tablet under fasting condition Period 4: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-348(2) | Drug | QD, PO |
| |
| CKD-828, D097, D337 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of CKD-348(2) | AUCt: Area under the concentration-time curve from time zero to time | 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 of CKD-348(2) | Cmax: Maximum plasma concentration of the drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of CKD-348(2) | AUCinf: Area under the concentration-time curve from zero up to ∞ | 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 of CKD-348(2) |
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Inclusion Criteria:
Healthy adult volunteers aged ≥ 19 years
Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
Those who meet the blood pressure criteria during screening tests:
Those 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 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.
Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
Those who exceed an alcohol and cigarette consumption than below criteria
Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism.
Those 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.
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| Name | Affiliation | Role |
|---|---|---|
| Yook-Hwan Noh, M.D., PhD. | Hplus YangJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus Yangji Hospital | Seoul | Gwanak-gu | 08779 | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Drug |
QD, PO |
|
Tmax: Time to maximum plasma concentration
| 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 of CKD-348(2) | AUCt/AUCinf | 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 of CKD-348(2) | T1/2: Terminal elimination half-life | 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 |
| D009750 | Nutritional and Metabolic Diseases |