Clinical Trial to Evaluate the Drug Drug Interaction of CKD-501 and D308

NCT ID: NCT03616392

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-25
• Study Completion Date: 2018-11-13

Brief Summary

Phase 1 trial to evaluate the drug drug interaction of CKD-501 and D308

Detailed Description

A randomized, open-label, multiple dose, 2-way crossover study to evaluate the drug drug interaction of CKD-501 and D308 in healthy volunteers

Conditions

Diabetes Mellitus, Type II

Study Design

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

Study Groups

Part 1: Group 1(Treatment A/Treatment B)

Period 1: Treatment A (D308 1T)/day for 5days, QD, PO Period 2: Treatment B (D308 1T + CKD-501 1T)/day for 5days, QD, PO

Group Type: EXPERIMENTAL

D308, CKD-501

Intervention Type: DRUG

1. D308

2. CKD-501: Lobeglitazone sulfate 0.5mg

Part 1: Group 2(Treatment B/Treatment A)

Period 1: Treatment B (D308 1T + CKD-501 1T)/day for 5days, QD, PO Period 2: Treatment A (D308 1T)/day for 5days, QD, PO

Group Type: EXPERIMENTAL

D308, CKD-501

Intervention Type: DRUG

1. D308

2. CKD-501: Lobeglitazone sulfate 0.5mg

Part 2: Group 1(Treatment C/Treatment B)

Period 1: Treatment C (CKD-501 1T)/day for 5days, QD, PO Period 2: Treatment B (D308 1T + CKD-501 1T)/day for 5days, QD, PO

Group Type: EXPERIMENTAL

D308, CKD-501

Intervention Type: DRUG

1. D308

2. CKD-501: Lobeglitazone sulfate 0.5mg

Part 2: Group 2(Treatment B/Treatment C)

Period 1: Treatment B (D308 1T + CKD-501 1T)/day for 5days, QD, PO Period 2: Treatment C (CKD-501 1T)/day for 5days, QD, PO

Group Type: EXPERIMENTAL

D308, CKD-501

Intervention Type: DRUG

1. D308

2. CKD-501: Lobeglitazone sulfate 0.5mg

Interventions

D308, CKD-501

1. D308

2. CKD-501: Lobeglitazone sulfate 0.5mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy adult older than 19 years at the time of screening

2. BMI 17.5~30.5kg/m2 and body weight more than 55kg

3. Subject who has no chronic disease within last 3 years and no symptoms or pathological findings

4. Suitable subject who is determined to be suitable at the time of screening such as laboratory tests(hematology, blood chemistry, urinalysis, virus/bacteriological test, etc.), sign of vitality, electrocardiogram

5. Subject who signed the written consent of the Chonbuk National University Hospital IRB to participate in this study with full understanding of the purpose and contents of the examination prior to the clinical trial

6. Subject who has will and ability to participate in clinical trials

Exclusion Criteria

1. Subject who has a history of clinical significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological or allergic diseases(except for asymptomatic seasonal allergies not treated at the time of administration) or evidence(except for simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)

2. Subject with a history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption

3. Clinical laboratory test results showing the following values

• ALT or AST > 2 times upper limit of normal range

4. Subject who has a history of regular alcohol consumption exceeding 210g/week within 6months of screening (1 glass of beer(5%)=10g, 1 glass of soju(20%)=8g, 1 glass of wine(12%)=12g)

5. Those taking other clinical trial drugs or bioequivalence test drugs within 3months before the first administration of clinical trial drug

6. Subject who has a systolic blood pressure of less than 100mmHg or more than 140mmHg or diastolic blood pressure of less than 60mmHg or more than 90mmHg of screening

7. Subject who has significant alcohol abuse or drug abuse within a year of screening

8. Those taking medication known to significantly induce or inhibit drug metabolizing enzymes within 30days prior to the first administration of clinical trial medication

9. More than 20 smokers per day within six months of screening

10. Those taking prescription or non-prescription drugs within 10days before the first administration of clinical trial medication

11. Those who donated whole blood within 2 months or those who donated the components within 1 month before the first administration of the clinical trial drug

12. Subject who has risk of serious or chronic medical, mental, or laboratory examinations that may increase the risk due to the administration of medicines for clinical trials and may interfere with the interpretation of test results

13. Patients who are known to be hypersensitive to the drug or its components

14. Patients with severe heart failure or heart failure(New York Heart Association(NYHA) Class 3, 4 heart patients)

15. Patients with hepatic impairment

16. Patients with a glomerular filtration rate(eGFR) less than 60ml/min/1.73m2, patients with end stage renal disease or dialysis

17. Patients with diabetic ketoacidosis, diabetic coma and total coma, patients with type 1 diabetes

18. Before and after surgery, severe infectious patients, severe trauma patients

19. Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

20. Pregnant and lactating women

21. Subject who is judged by the investigator to be ineligible to participate in the clinical trial

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

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chonbuk National University Hospital

Jeonju, , South Korea

Countries

South Korea

References

Jang K, Jeon JY, Moon SJ, Kim MG. Evaluation of the Pharmacokinetic Interaction Between Lobeglitazone and Dapagliflozin at Steady State. Clin Ther. 2020 Feb;42(2):295-304. doi: 10.1016/j.clinthera.2020.01.003. Epub 2020 Jan 25.

Reference Type: DERIVED

PMID: 31992459 (View on PubMed)

Other Identifiers

19DDI18013

Identifier Type: -

Identifier Source: org_study_id