A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-383.

Type2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-383 and Co-administration of CKD-501, D745, D150 Under Fed Condition in Healthy Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810676
• Other study ID #: A101_02BE2020
• Status: Completed
• Phase: Phase 1
• Start date: April 16, 2021
• Est. completion date: May 26, 2021

Study information

• Verified date: June 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical trial to evaluate the pharmacokinetic profiles and safety of CKD-383.

Description:

A phase 1 clinical trial to evaluate pharmacokinetics and safety in healthy adult after oral administration of CKD-383 and co-administration of CKD-501, D745, D150.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 26, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Healthy adult volunteers aged between 19 and 55 years old.

2. Weight = 55kg(men) or =50kg(women),

3. Calculated body mass index(BMI) of 18.5 to 27.0kg/m2

• Body Mass Index(BMI) = Weight(kg) / [Height(m)]2

4. Women must meet one of the criteria written in below:

• Menopause (No menstruation for 2 years)

• Sterilization (hysterectomy or Oophorectomy, Tubal ligation etc.)

5. Men agree to contraception and not to donate sperm during the participation of clinical trial.

6. Those who voluntarily decide to participate and agree to comply with the cautions after fully understand of the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who have a clinically significant disease or medical history of hepatic-biliary system issues, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Digestive system disorder, Endocrine system disorder, Cardiovascular disorder, Blood tumor and/or mental health problems.

2. Those who have signs and symptoms of clinically significant dehydration or who are vulnerable to dehydration by poor oral intake.

3. Those who receive intravenous administration of radioactive iodine contrast agents (for Urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48hours before the first administration of investigational product.

4. Those who have severe urinary tract infection or have a past medical history of it.

5. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.

6. 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

7. Those who have history of hypersensitivity to active pharmaceutical ingredient(Lobeglitazone, Empagliflozin, Metformin) or additives.

8. Those who have the test results written in below:

• AST/ALT > 1.25 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, PRP

• Under 5 min resting condition, systolic blood pressure >150mmHg or <90mmHg, Diastolic blood pressure >100mmHg, or <50mmHg

9. Those who have a drug abuse history within one year or positive reaction on urine drug screening test

10. 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.

11. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of investigational product

12. 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)

13. Those who took grapefruit before the first administration of investigational product or can't stop taking grapefruit during hospitalization period

14. Those who received investigational product by participating in other clinical trial within 6 months before the first administration of investigational product

15. Those who donated whole blood within 2 months or apheresis within 1 month

16. Those who received transfusion within 1 month

17. Those who are pregnant or breastfeeding

18. Those who are deemed inappropriate to participate in clinical trial by investigators

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Drug:
• CKD-501, D745, D150
QD, PO
• CKD-383
QD, PO

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul	Yonsei-ro, Seodaemun-gu 50-1

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast of CKD-383	AUClast: Area under the concentration-time curve from time zero to the last measurable concetnration time	0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Primary	Cmax of CKD-383	Cmax: Maximum plasma concentration of the drug	0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Secondary	AUCinf of CKD-383	AUCinf: Area under the concentration-time curve from zero up to infinity	0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Secondary	Tmax of CKD-383	Tmax: Time to maximum plasma concentration	0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Secondary	T1/2 of CKD-383	T1/2: Terminal elimination half-life	0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Secondary	Vd/F of CKD-383	Vd/F: Volume of distribution	0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Secondary	CL/F of CKD-383	CL/F: Clearance	0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)