A Clinical Trial to Evaluate the Tolerability and Pharmac... | NCT05749861

NCT05749861

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

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 condition Period 2: CKD-348(5) - 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(5) - A single oral dose of 1 tablet under fasting condition	Drug: CKD-348(5) Drug: CKD-828, D097, D337
Sequence 2	Experimental	Period 1: CKD-348(5) - 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(5) - 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(5) Drug: CKD-828, D097, D337

Name	Type	Description	Arm Group Labels	Other Names
CKD-348(5)	Drug	QD, PO	Sequence 1 Sequence 2
CKD-828, D097, D337

Measure	Description	Time Frame
AUCt of CKD-348(5)	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(5)	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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult volunteers aged ≥ 19 years.
Body weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2
Those who meet the 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 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 ECG results at screening.
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 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 and those who take drug could affect to clinical trial within 10 days 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 criteria write below within 1 month before the first administration of investigational products.
- Alcohol: Man - 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
- 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 trial by investigators.
Woman who are pregnant or breastfeeding.

ID	Term
D006973	Hypertension
D050171	Dyslipidemias