A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348
NCT ID: NCT04660370
Last Updated: 2024-01-23
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
70 participants
INTERVENTIONAL
2021-01-09
2021-04-15
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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Sequence 1
Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition
Period 2: CKD-348- A single oral dose of 1 tablet under fasting condition
Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition
Period 4: CKD-348- A single oral dose of 1 tablet under fasting condition
CKD-348
QD, PO
CKD-828, D097, D337
QD, PO
Sequence 2
Period 1: CKD-348- A single oral dose of 1 tablet under fasting condition
Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition
Period 3: CKD-348- A single oral dose of 1 tablet under fasting condition
Period 4: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition
CKD-348
QD, PO
CKD-828, D097, D337
QD, PO
Interventions
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CKD-348
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 meet the 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 diseases or chronic diseases and have no abnormal symptoms or findings.
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
6. Those who agree to contraception during the participation of clinical trial.
7. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
Exclusion Criteria
2. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
3. Those who donated whole blood or apheresis within 2 months or 1 month respectfully, or received blood transfusion within a month.
4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
5. Those who exceed an alcohol and cigarette consumption than below criteria
* Alcohol: Man\_21 glasses/week, Woman\_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
* Smoking: 20 cigarettes/day
6. Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism.
7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
8. Those who are deemed insufficient to participate in this clinical study by investigators.
9. Woman who are pregnant or breastfeeding.
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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Noh Yook-Hwan, 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_08BE2009
Identifier Type: -
Identifier Source: org_study_id
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