A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-375

NCT ID: NCT04221360

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-29
• Study Completion Date: 2020-06-08

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-375.

Detailed Description

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of High Dose CKD-375 and D390 in Healthy Adults.

Conditions

Type2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

• Period 1: D390
• Period 2: CKD-375

Group Type: EXPERIMENTAL

CKD-375

Intervention Type: DRUG

Test drug, QD, PO

D390

Intervention Type: DRUG

Reference drug, QD, PO

Group 2

• Period 1: CKD-375
• Period 2: D390

Group Type: EXPERIMENTAL

CKD-375

Intervention Type: DRUG

Test drug, QD, PO

D390

Intervention Type: DRUG

Reference drug, QD, PO

Interventions

CKD-375

Test drug, QD, PO

Intervention Type: DRUG

D390

Reference drug, QD, PO

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy adult who is 19 ~ 55 years at the time of screening

2. Body weight more than 55 kg for male and more than 50kg for female

3. BMI more than 18.5 kg/m2 or less than 27.0 kg/m2

4. Females must be menopause or surgical infertility

5. Males who have consented to the use of appropriate pregnancy contraceptive methods up to 28 days after the last investigational product and not to provide sperm

6. Subjects who voluntarily decided to participate and informed consent based upon understanding on the study.

Exclusion Criteria

1. Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder

2. Subjects who has clinically significant dehydration or is vulnerable to dehydration due to poor oral intake

3. Subjects who underwent intravenous administration of radioactive iodine contrast agents (e.g., intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48 hours prior to the first dose of the investigational product

4. Subjects who have a significant urinary tract infection or have such a history

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

6. Subjects who have a history of gastrointestinal disorders (Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the drug

7. Subjects who have a history of clinically significant hypersensitivity to drugs or additives, including components of the investigational product (empagliflozin, metformin)

8. Subjects who are deemed unsuitable as subjects in the screening test performed within 28 days before the administration of investigational product

• AST, ALT> UNL(Upper Normal Limit)x1.25
• Total bilirubin > UNL(Upper Normal Limit)x1.5
• eGFR (Estimated Glomerular Filtration Rate) <60 mL / min / 1.73m2 using the MDRD (Modification of Diet in Renal Disease) formula
• Positive immunologic serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
• After resting for more than 5 minutes, systolic blood pressure> 150 mmHg or < 90 mmHg, diastolic blood pressure> 100 mmHg or <50 mmHg

9. Subjects who have had a history of drug abuse within one year of screening or have tested positive on urine drug screening test

10. Pregnant or lactating women

11. Subjects who have consistently excessively smoked or consumed caffeine or alcohol (caffeine:> 5 cups / day, alcohol:> 210 g / week, cigarettes:> 10 cigarettes / day) or cannot stop smoking, consuming caffeine and alcohol during hospitalization

12. Subjects who took any of the following drugs except for topical without serious systemic absorption and hormonal contraceptives and are deemed that the administered drug may affect in the study or the safety of the subject by the investigator

• Ethical-the-counter (ETC) drugs and herbal medicines within 14 days of the first administration of the investigational drug
• Over-the-counter (OTC) drugs, including health foods and vitamin preparations, within 7 days of the first dose of the investigational product
• Drugs administered by depot injection or through iomplantation in the human body within 30 days of the first dose of investigational product

13. Subjects who have received the investigational product by participating in other clinical trials (including bioequivalence studies) within 180 days before the first dose of the investigational product (For biological agents, this may be based on a longer period of time, considering the half-life)

14. Subjects who donated whole blood within 60 days before the first dose of the investigational product or donated component blood donation within 30 days

15. Subjects who were deemed to be inappropriate to participate in the study by the investigator judgment

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Soo Park, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Yonsei University Severance Hospital

Soeul, , South Korea

Countries

South Korea

Central Contacts

Min Soo Park, M.D., Ph.D.

Role: CONTACT

minspark@yuhs.ac

+82-2-2228-0401

Other Identifiers

A92_02BE1920

Identifier Type: -

Identifier Source: org_study_id