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

NCT04221360 | Unknown Phase 1

• 1 other identifier: A92_02BE1920
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Cmax of D390 and CKD-375

  Maximum plasma concentration of D390 and CKD-375

  0(predose)~48 hours

• AUClast of D390 and CKD-375

  Area under the plasma concentration-time curve to last concentration of D390 and CKD-375

  0(predose)~48 hours

Secondary Outcomes (5)

• AUCinf of D390 and CKD-375

  0(predose)~48 hours

• Tmax of D390 and CKD-375

  0(predose)~48 hours

• t1/2 of D390 and CKD-375

  0(predose)~48 hours

• Vd/F of D390 and CKD-375

  0(predose)~48 hours

• CL/F of D390 and CKD-375

  0(predose)~48 hours

Study Arms (2)

Group 1

EXPERIMENTAL

* Period 1: D390 * Period 2: CKD-375

Drug: CKD-375; Drug: D390

Group 2

EXPERIMENTAL

* Period 1: CKD-375 * Period 2: D390

Drug: CKD-375; Drug: D390

Interventions

CKD-375 DRUG

Test drug, QD, PO

Group 1; Group 2

D390 DRUG

Reference drug, QD, PO

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult who is 19 \~ 55 years at the time of screening
• Body weight more than 55 kg for male and more than 50kg for female
• BMI more than 18.5 kg/m2 or less than 27.0 kg/m2
• Females must be menopause or surgical infertility
• 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
• Subjects who voluntarily decided to participate and informed consent based upon understanding on the study.

You may not qualify if:

• Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
• Subjects who has clinically significant dehydration or is vulnerable to dehydration due to poor oral intake
• 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
• Subjects who have a significant urinary tract infection or have such a history
• Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• 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
• Subjects who have a history of clinically significant hypersensitivity to drugs or additives, including components of the investigational product (empagliflozin, metformin)
• 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
• Subjects who have had a history of drug abuse within one year of screening or have tested positive on urine drug screening test
• Pregnant or lactating women

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Yonsei University Severance Hospital

Soeul, South Korea

Location

Study Officials

• Min Soo Park, M.D., Ph.D.

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+82-2-2228-0401; minspark@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: January 29, 2020
• Primary Completion: March 6, 2020
• Study Completion: June 8, 2020
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

KR (1)