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

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-396 and Co-administration of CKD-501 and D759 in Healthy Adults

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

Study Overview

• Status: Unknown
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Drug: CKD-501 and D759; Drug: CKD-396

Detailed Description

Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-396 and Co-administration of CKD-501 and D759 in Healthy Adults

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Min Soo Park, Ph.D. M.D; Phone Number: +82-2-2228-0401; Email: minspark@yuhs.ac

Study Locations

• Korea, Republic of
  • Soeul, Korea, Republic of
    • Yonsei University Severance Hospital
    • Contact: Min Soo Park, Ph.D. M.D; Phone Number: +82-2-2228-0401; Email: minspark@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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, hematooncology, cardiovascular systemic disease or psychosis disorder
2. Subjects who have diabetic ketoacidoisis, diabetic coma, diabetic precoma, Type 1 diabetes
3. Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
4. 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
5. 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
6. Subjects who have severe infectious disease and severe trauma before and after operation

7. 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
8. Subjects who have had a history of drug abuse within one year of screening or have tested positive on urine drug screening test
9. Pregnant or lactating women
10. 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

11. Subjects who judged to able to affect in the study or in the subject's safety by the investigator for the following reasons

    • 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
12. 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)
13. Subjects who donated whole blood within 60 days before the first dose of the investigational product or donated component blood donation within 30 days
14. Subjects who received a blood transfusion within 60 days before the first dose of the investigational product
15. Subjects who were deemed to be inappropriate to participate in the study by the investigator judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1; Period 1: CKD-501 and D759; Period 2: CKD-396	Drug: CKD-501 and D759; Reference drug, CKD-501 1T and D759 1T, QD, PO; Drug: CKD-396; Reference drug, CKD-396 1T, QD, PO
EXPERIMENTAL: Group 2; Period 1: CKD-396; Period 2: CKD-501 and D759	Drug: CKD-501 and D759; Reference drug, CKD-501 1T and D759 1T, QD, PO; Drug: CKD-396; Reference drug, CKD-396 1T, QD, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 24, 2020
• Primary Completion (ANTICIPATED): April 10, 2020
• Study Completion (ANTICIPATED): July 16, 2020

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (ACTUAL): January 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: A65_03BE1921

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No