A Clinical Trial to Compare the Pharmacokinetics and Tole... | NCT04258865

NCT04258865

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence 1	Experimental	Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions	Drug: CKD-348 F1 Drug: CKD-348 F2 Drug: CKD-828, D097, D337
Sequence 2	Experimental	Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions	Drug: CKD-348 F1 Drug: CKD-348 F2 Drug: CKD-828, D097, D337
Sequence 3	Experimental	Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions	Drug: CKD-348 F1 Drug: CKD-348 F2 Drug: CKD-828, D097, D337
Sequence 4	Experimental	Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions

Name	Type	Description	Arm Group Labels	Other Names
CKD-348 F1	Drug	QD, PO	Sequence 1 Sequence 2 Sequence 3 Sequence 4 Sequence 5 Sequence 6

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCt of CKD-348	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	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

Secondary Outcomes

Measure	Description	Time Frame
AUCinf of CKD-348	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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult volunteers aged ≥ 19-year-old
Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg
Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
Those who agree to contraception during the participation of clinical trial
Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion Criteria:

Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month
Those who has a history of gastrointestinal surgery (
Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day
Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency
Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
Women who are pregnant or who may be pregnant and breastfeed

ID	Term
D006973	Hypertension
D050171	Dyslipidemias