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This study is a randomized, open-label, single dosing, 3-treatment, 6-sequence, 3-period, crossover-design study to compare the pharmacokinetics and safety of D113 with CKD-349 in healthy volunteers.
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: Entresto 200mg / Test drug: 1) CKD-349 F1 Tab. 2) CKD-349 F2 Tab.
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-T1-T2 | Experimental |
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| T2-R-T1 | Experimental |
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| T1-T2-R | Experimental |
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| T2-T1-R | Experimental |
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| T1-R-T2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-349 F1 Tab. | Drug | 1T Single does |
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| Measure | Description | Time Frame |
|---|---|---|
| AUCt of CKD-349, D113 | Area under the CKD-349/D113 concentration in blood-time curve from zero to final | Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours |
| Cmax of CKD-349, D113 | The maximum CKD-349/D113 concentration in blood sampling time t | Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours |
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Inclusion Criteria:
Healthy adults over the age of 19 years at the time of screening
Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) < 29.9kg/m2 and total body weight ≥ 55 kg
* BMI = Weight(kg)/ Height(m)2
Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed within 28 days to the scheduled date of first administration of the investigational product
In case of female subjects, those who were confirmed to be non-pregnant at screening
Individuals who agreed to the use of appropriate medically recognized contraceptive methods themselves or their spouse (or partner) from the first administration of the investigational product to the 7th day of last administration. And in case of male subjects, those who agreed not donation of sperm, in case of female subjects, those who agreed not to be pregnant or breast-feeding from the first administration of the investigational product to the 7th day of last administration
Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial.
Exclusion Criteria:
Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
Individuals with symptoms of acute disease within 28 days prior to the scheduled date of first administration of the investigational product
Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
Individuals with a medical history or current symptoms that fall under one or more of the following who are judged to be concerned about the use of investigational product
Following vital signs results at screening
Individuals with the following results at screening test:
Individuals with a medical history of significant drug abuse or positive for abuse drug in urine test results at screening
Individuals who had taken ethical(ETC) or over the counter(OTC) within the 10 days prior to the first dose of investigational product
Individuals who donated whole blood within the 8 weeks, or donated blood components within 4 weeks prior to the first dose of the investigational product or received a blood transfusion with 4 weeks
Individuals who had been administered investigational product(s) of other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
Individuals taking medication known to significantly induce or inhibit drug metabolizing enzymes within 1 month before the first administration of clinical trial drug
Individuals who drunk grapefruit juice or caffeine more than 5 cup per day within 3 months prior to first dose of this study or cannot quit drinking during clinical trials period
A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml of pure alcohol) prior to screening or individuals who cannot quit drinking from 48hr prior to the first dose to end of last blooding (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
Individuals who exceed the smoking amount of 10 cigarettes per day within 3 months prior to first dose of this study or cannot quit smoking during clinical trials period
Individuals who cannot eat standard meal in institution
Individuals who were deemed to be inappropriate to participate in the study by the investigator
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| Name | Affiliation | Role |
|---|---|---|
| Jang Hee Hong | Chungnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | South Korea |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| R-T2-T1 |
| Experimental |
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| CKD-349 F2 Tab. | Drug | 1T Single does |
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| D113 Tab. | Drug | 1T Single does |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |