A Clinical Trial to Evaluate the Pharmacokinetics and Tol... | NCT04587206

NCT04587206

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental: Sequence 1	Experimental	Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348- 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- A single oral dose of 1 tablet under fasting condition	Drug: CKD-348 Drug: CKD-828, D097, D337
Experimental: Sequence2	Experimental	Period 1: CKD-348- 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- 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	Drug: CKD-348 Drug: CKD-828, D097, D337

Name	Type	Description	Arm Group Labels	Other Names
CKD-348	Drug	QD, PO	Experimental: Sequence 1 Experimental: Sequence2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCt of CKD-348	AUCt: Area under the concentration-time curve from time zero to time	[Time Frame: 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	[Time Frame: 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 ∞	[Time Frame: 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 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:

A. Systolic Blood Pressure: 90 to 139 mmHg B. Diastolic Blood Pressure: 60 to 89 mmHg
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 2 months or 1 month 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 A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. Smoking: 20 cigarettes/day
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.

ID	Term
D006973	Hypertension
D050171	Dyslipidemias