A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Adult Volunteers
NCT ID: NCT04223895
Last Updated: 2020-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2020-02-01
2020-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group 1
Period 1: D012, D326, D337(3 tabs, once) / Period 2: CKD-386 F1(1 tab, once)/ Period 3: CKD-386 F2(1 tab, once)
CKD-386 Formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
CKD-386 Formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
D012, D326 and D337
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
Group 2
Period 1: D012, D326, D337(3 tabs, once) / Period 2: CKD-386 F2(1 tab, once)/ Period 3: CKD-386 F1(1 tab, once)
CKD-386 Formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
CKD-386 Formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
D012, D326 and D337
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
Group 3
Period 1: CKD-386 F1(1 tab, once) / Period 2: D012, D326, D337(3 tabs, once) Period 3: CKD-386 F2(1 tab, once)
CKD-386 Formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
CKD-386 Formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
D012, D326 and D337
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
Group 4
Period 1: CKD-386 F1(1 tab, once) / Period 2: CKD-386 F2(1 tab, once) / Period 3: D012, D326, D337(3 tabs, once)
CKD-386 Formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
CKD-386 Formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
D012, D326 and D337
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
Group 5
Period 1: CKD-386 F2(1 tab, once) / Period 2: D012, D326, D337(3 tabs, once)/ Period 3: CKD-386 F1(1 tab, once)
CKD-386 Formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
CKD-386 Formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
D012, D326 and D337
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
Group 6
Period 1: CKD-386 F2(1 tab, once) / Period 2: CKD-386 F1(1 tab, once) / Period 3: D012, D326, D337(3 tabs, once)
CKD-386 Formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
CKD-386 Formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
D012, D326 and D337
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
Interventions
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CKD-386 Formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
CKD-386 Formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
D012, D326 and D337
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Those who weigh more than 50kg (45kg or more for women) at the screening visit and have a body mass index (BMI) within the range of 18-30kg/m\^2
3. Those who meet the following conditions of blood pressure measured in a sitting position after sufficient rest at the screening visit
* Systolic blood pressure: 90mmHg or more and 139mmHg or less
* Diastolic blood pressure: 60mmHg or more and 89mmHg or less
4. Those who no congenital or chronic disease based on screening and no pathological symptoms or findings in medical examination results (e.g. EEG, ECG, chest and gastroscopy or gastrointestinal radiographs, if necessary)
5. The person in charge of the examination (or authorized test physician) who has determined that the test subject is suitable for the diagnostic test and electrocardiogram test such as hematology test, blood chemistry test, serology test and urine test performed according to the characteristics of the investigational drug product
6. Persons agreeing to exclude the possibility of pregnancy using appropriate contraceptive methods and not providing sperm or eggs from the date of first administration of the investigational drug to the 14th day after the last administration of the investigational drug
Exclusion Criteria
2. Those who used drugs that induce and inhibit metabolic enzymes, such as barbital drugs, within one month before the first dose, or who used drugs that may interfere with this test within 10 days before the first dose
3. Those who have donated whole blood within 2 months before the first dose or component donation within 1 month, or have transfused within 1 month
4. Those who have had a history of gastrointestinal resection that may affect the absorption of the investigational drug (except appendectomy and hernia surgery)
5. A person who meets the following conditions within one month before the first administration date
* Excess alcohol: 21 cups / week for men and 14 cups / week for women.
\[1 glass = 50 mL of shochu or 30 mL of liquor or 250 mL of beer\]
* Smokers exceeding 20 cigarettes per day
6. Patients with the following diseases
* Patients with hypersensitivity to the main constituents or components of the investigational drug
* Severe hepatic impairment, biliary atresia or cholestasis
* Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists
* Diabetes mellitus
* Patients with moderate to severe renal impairment \[glomerular filtration rate (eGFR) \<60 mL / min / 1.73m\^2\]
* Renal vascular hypertension patients
* Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit
* Patients with myopathy or have a history of family or genetic history of myopathy
* Hypothyroidism
* If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs
7. Genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
9. In the case of female volunteers, the suspected or lactating woman
19 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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70-4665-9174 70-4665-9174
Role: PRINCIPAL_INVESTIGATOR
H Plus Yangji Hospital
Central Contacts
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Other Identifiers
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A83_04BE1917P
Identifier Type: -
Identifier Source: org_study_id
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