A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D745 and D150
NCT ID: NCT04334213
Last Updated: 2020-10-30
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
48 participants
INTERVENTIONAL
2020-05-07
2020-08-05
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-501 - A single oral dose of 1 tablet under fasting conditions for 5 days.
Period 2: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets).
CKD-501
QD, PO
CKD-501, D745, D150
QD, PO
Sequence 2
Period 1: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets). Period 2: CKD-501 - A single oral dose of 1 tablet under fasting conditions for 5 days
CKD-501
QD, PO
CKD-501, D745, D150
QD, PO
Sequence 3
Period 1: D745, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D745: 1 tablet, D150: 2 tablets). Period 2: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets).
D745, D150
QD, PO
CKD-501, D745, D150
QD, PO
Sequence 4
Period 1: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets). Period 2: D745, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D745: 1 tablet, D150: 2 tablets).
D745, D150
QD, PO
CKD-501, D745, D150
QD, PO
Interventions
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CKD-501
QD, PO
D745, D150
QD, PO
CKD-501, D745, D150
QD, PO
Eligibility Criteria
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Inclusion Criteria
2. Weight ≥ 55kg (men) or ≥ 50kg (women), with calculated body mass index(BMI) of 18.5 to 27.0 kg/m2
3. Women must meet one of the criteria written below:
* Menopause (No menstruation for 2 years)
* Sterilization (Hysterectomy or Oophorectomy, Tubal ligation etc.)
4. Men agree to contraception \& won't donate sperm during the participation of clinical trial
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. Those who have clinically significant dehydration or vulnerable to dehydration by poor oral intake
3. Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48 hours before the first administration of investigational product
4. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
5. Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of drug
6. Those who have history of hypersensitivity to active pharmaceutical ingredient (Lobeglitazone, Empagliflozin, Metformin) or additives.
7. Those who have the test results written below
* AST, ALT \> 1.25 times higher than upper normal level
* Total bilirubin \> 1.5 times higher than upper normal level
* eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) \< 60 mL/min/1.73m2
* "Positive" or "Reactive" test result of Hepatitis B \& C, HIV, RPR
* Under 5 min resting condition, systolic blood pressure \>150 mmHg or \<90 mmHg, diastolic blood pressure \>100 mmHg or \<50 mmHg
8. Those who have a drug abuse history within one year or positive reaction on urine drug screening test
9. Those who received following drugs, which may affect results of clinical trial and safety Ethical-the-counter (ETC) drugs and herbal medicines within 14 days before the first administration of the investigational drug Over-the-counter (OTC) drugs, health foods and vitamin preparations within 7 days before the first administration of the investigational product
10. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of investigational product
11. Those who exceeding an alcohol and smoke consumption criteria or can't stop smoking, consuming alcohol and caffeine during hospitalization period Criteria: Caffeine \> 5 cups/day, Alcohol \> 210 g/week, Smoke \> 10 cigarettes/day
12. Those who took grapefruit before the first administration of investigational product or can't stop taking grapefruit during hospitalization period
13. Those who received investigational product by participating in other clinical trial within 6 months before the first administration of investigational product
14. Those who donated whole blood within 2 months or apheresis within 1 month
15. Those who received transfusion within 1 month
16. Those who are pregnant or breastfeeding
17. Those who are deemed inappropriate to participate in clinical trial by investigators
19 Years
55 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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Choon Ok Kim, M.D., PhD.
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Severance Hospital
Seoul, , South Korea
Countries
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References
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Kim H, Kim CO, Park H, Park MS, Kim D, Hong T, Shin Y, Jin BH. Evaluation of pharmacokinetic interactions between lobeglitazone, empagliflozin, and metformin in healthy subjects. Transl Clin Pharmacol. 2023 Mar;31(1):59-68. doi: 10.12793/tcp.2023.31.e4. Epub 2023 Mar 23.
Other Identifiers
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A101_01DDI1927
Identifier Type: -
Identifier Source: org_study_id