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

Diabetes Mellitus, Type II Clinical Trial

Official title:

A Randomized, Open-label, Multiple Dose, 2-way Crossover Study to Evaluate the Drug Drug Interaction of CKD-501 and D308 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616392
• Other study ID #: 19DDI18013
• Status: Completed
• Phase: Phase 1
• Start date: July 25, 2018
• Est. completion date: November 13, 2018

Study information

• Verified date: November 2018
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 13, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Drug:
• D308, CKD-501
D308 CKD-501: Lobeglitazone sulfate 0.5mg

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Part 1) AUCss,tau of D308	Area under the curve of D308 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Primary	(Part 1) Css,max of D308	Max Concentration of D308 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Primary	(Part 2) AUCss,tau of CKD-501	Area under the curve of CKD-501 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Primary	(Part 2) Css,max of CKD-501	Max Concentration of CKD-501 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 1) Css,min of D308	Min concentration of D308 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 1) Css,av of D308	average concentration of D308 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 1) Tss,max of D308	time of Max concentration of D308 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 1) t1/2 of D308	half-life time of D308	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 1) CLss/F of D308	Apparent clearance of D308 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 1) Vdss/F of D308	Apparent volume of distribution of D308 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 1) Fluctuation[(Css,max-Css,min)/Css,av] of D308	Fluctuation concentration of D308 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 1) Swing[(Css,max-Css,min)/Css,min] of D308	Swing concentration of D308 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 2) Css,min of CKD-501	Min concentration of CKD-501 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 2) Css,av of CKD-501	average concentration of CKD-501 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 2) Tss,max of CKD-501	time of Max concentration of CKD-501 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 2) t1/2 of CKD-501	half-life time of CKD-501	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 2) CLss/F of CKD-501	Apparent clearance of CKD-501 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 2) Vdss/F of CKD-501	Apparent volume of distribution of CKD-501 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 2) Fluctuation[(Css,max-Css,min)/Css,av] of CKD-501	Fluctuation concentration of CKD-501 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary	(Part 2) Swing[(Css,max-Css,min)/Css,min] of CKD-501	Swing concentration of CKD-501 at steady state	Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours