A Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-396

NCT04246190 | Unknown Phase 1

• 1 other identifier: A65_03BE1921
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of CKD-396.

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Cmax of CKD-501, D759 and CKD-396

  Maximum plasma concentration of CKD-501, D759 and CKD-396

  0(predose)~48 hours

• AUClast of CKD-501, D759 and CKD-396

  Area under the plasma concentration-time curve to last concentration of CKD-501, D759 and CKD-396

  0(predose)~48 hours

Study Arms (2)

Group 1

EXPERIMENTAL

* Period 1: CKD-501 and D759 * Period 2: CKD-396

Drug: CKD-501 and D759; Drug: CKD-396

Group 2

EXPERIMENTAL

* Period 1: CKD-396 * Period 2: CKD-501 and D759

Drug: CKD-501 and D759; Drug: CKD-396

Interventions

CKD-501 and D759 DRUG

Reference drug, CKD-501 1T and D759 1T, QD, PO

Group 1; Group 2

CKD-396 DRUG

Reference drug, CKD-396 1T, 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, hematooncology, cardiovascular systemic disease or psychosis disorder
• Subjects who have diabetic ketoacidoisis, diabetic coma, diabetic precoma, Type 1 diabetes
• 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(lobeglitazone, sitagliptin) and same class drug with thiazolidinediones
• Subjects who have severe infectious disease and severe trauma before and after operation
• 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
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Yonsei University Severance Hospital

Soeul, South Korea

Location

MeSH Terms

Interventions

lobeglitazone

Study Officials

• Min Soo Park, Ph.D. M.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Soo Park, Ph.D. M.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 28, 2020
• First Posted: January 29, 2020
• Study Start: February 24, 2020
• Primary Completion: April 10, 2020
• Study Completion: July 16, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

KR (1)