A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348
NCT ID: NCT04258865
Last Updated: 2020-06-05
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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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2020-03-25
2020-05-13
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-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
CKD-348 F1
QD, PO
CKD-348 F2
QD, PO
CKD-828, D097, D337
QD, PO
Sequence 2
Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
CKD-348 F1
QD, PO
CKD-348 F2
QD, PO
CKD-828, D097, D337
QD, PO
Sequence 3
Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
CKD-348 F1
QD, PO
CKD-348 F2
QD, PO
CKD-828, D097, D337
QD, PO
Sequence 4
Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
CKD-348 F1
QD, PO
CKD-348 F2
QD, PO
CKD-828, D097, D337
QD, PO
Sequence 5
Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
CKD-348 F1
QD, PO
CKD-348 F2
QD, PO
CKD-828, D097, D337
QD, PO
Sequence 6
Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
CKD-348 F1
QD, PO
CKD-348 F2
QD, PO
CKD-828, D097, D337
QD, PO
Interventions
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CKD-348 F1
QD, PO
CKD-348 F2
QD, PO
CKD-828, D097, D337
QD, PO
Eligibility Criteria
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Inclusion Criteria
2. Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
3. Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg
4. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
6. Those who agree to contraception during the participation of clinical trial
7. 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. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
3. Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month
4. Those who has a history of gastrointestinal surgery (
5. Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day
6. Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency
7. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
9. Women who are pregnant or who may be pregnant and breastfeed
19 Years
65 Years
ALL
Yes
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Yook-Hwan Noh, M.D., PhD.
Role: PRINCIPAL_INVESTIGATOR
H Plus Yangji Hospital
Locations
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H Plus Yangji Hospital
Seoul, Gwanak-gu, South Korea
Countries
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Other Identifiers
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A86_05BE1916P
Identifier Type: -
Identifier Source: org_study_id
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