Clinical Study to Investigate the PK Profiles and Safety... | NCT04651881

NCT04651881

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

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
Group 1	Experimental	Period 1: Reference drug Period 2: Test drug 1 Period 3: Test drug 2	Drug: Reference drug Drug: Test drug 1 Drug: Test drug 2
Group 2	Experimental	Period 1: Test drug 2 Period 2: Reference drug Period 3: Test drug 1	Drug: Reference drug Drug: Test drug 1 Drug: Test drug 2
Group 3	Experimental	Period 1: Test drug 1 Period 2: Test drug 2 Period 3: Reference drug	Drug: Reference drug Drug: Test drug 1 Drug: Test drug 2
Group 4	Experimental	Period 1: Test drug 2 Period 2: Test drug 1 Period 3: Reference drug	Drug: Reference drug Drug: Test drug 1 Drug: Test drug 2
Group 5	Experimental	Period 1: Test drug 1 Period 2: Reference drug Period 3: Test drug 2	Drug: Reference drug Drug: Test drug 1 Drug: Test drug 2

Name	Type	Description	Arm Group Labels	Other Names
Reference drug	Drug	1 Cap., single oral administration under fed condition	Group 1 Group 2 Group 3 Group 4 Group 5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCt of CKD-385	Area under the concentration-time curve from time zero to time of CKD-385	Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Cmax of CKD-385	Maximum plasma concentration of CKD-385	Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

Secondary Outcomes

Measure	Description	Time Frame
AUCinf of CKD-385	Area under the concentration-time curve from zero up to infinity of CKD-385	Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Tmax of CKD-385

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult aged more than 19 at the time of screening
Those who had 18.0kg/m² ≤ Body Mass Index (BMI) < 30.0kg/m²

# BMI=Weight(kg) / Height(m)²
Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.
Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.
Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations.
Those who agree to double contraception method from the 1st dministration of the investigational product until 7 days after the last administration of investigational product.

Exclusion Criteria:

Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, mpacted teeth, wisdom teeth).
Those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug.
Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.
Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.
Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.
Those who have taken any drugs that may affect the clinical trial within 10 days.
Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products.
Those who is unable to consume a high-fat meal provided during the study.
Those who are deemed insufficient to participate in this clinical study by investigators.