A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers
NCT ID: NCT03920579
Last Updated: 2019-04-19
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
2019-04-01
2019-05-31
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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Sequence 1
Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(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
D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Sequence 2
Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(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
D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Sequence 3
Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(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
D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Sequence 4
Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013
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
D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Sequence 5
Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(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
D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Sequence 6
Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(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
D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) 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
D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2
3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
4. Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests
5. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
Exclusion Criteria
2. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
3. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
19 Years
45 Years
MALE
Yes
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Dongseong Shin, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Clinical Trials Center, Gil Medical Center, Incheon, Korea
Locations
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Gachon University Gil Medical Center
Incheon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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183PK18034
Identifier Type: -
Identifier Source: org_study_id
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