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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT03616392
Collaborator
(none)
41
Enrollment
1
Location
4
Arms
3.6
Actual Duration (Months)
11.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: D308, CKD-501
 Phase 1

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

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 25, 2018
Actual Primary Completion Date :
Sep 17, 2018
Actual Study Completion Date :
Nov 13, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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

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

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

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

Outcome Measures

Primary Outcome Measures

  1. (Part 1) AUCss,tau 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]

    Area under the curve of D308 at steady state

  2. (Part 1) Css,max 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]

    Max Concentration of D308 at steady state

  3. (Part 2) AUCss,tau 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]

    Area under the curve of CKD-501 at steady state

  4. (Part 2) Css,max 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]

    Max Concentration of CKD-501 at steady state

Secondary Outcome Measures

  1. (Part 1) Css,min 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]

    Min concentration of D308 at steady state

  2. (Part 1) Css,av 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]

    average concentration of D308 at steady state

  3. (Part 1) Tss,max 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]

    time of Max concentration of D308 at steady state

  4. (Part 1) t1/2 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]

    half-life time of D308

  5. (Part 1) CLss/F 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]

    Apparent clearance of D308 at steady state

  6. (Part 1) Vdss/F 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]

    Apparent volume of distribution of D308 at steady state

  7. (Part 1) Fluctuation[(Css,max-Css,min)/Css,av] 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]

    Fluctuation concentration of D308 at steady state

  8. (Part 1) Swing[(Css,max-Css,min)/Css,min] 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]

    Swing concentration of D308 at steady state

  9. (Part 2) Css,min 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]

    Min concentration of CKD-501 at steady state

  10. (Part 2) Css,av 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]

    average concentration of CKD-501 at steady state

  11. (Part 2) Tss,max 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]

    time of Max concentration of CKD-501 at steady state

  12. (Part 2) t1/2 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]

    half-life time of CKD-501

  13. (Part 2) CLss/F 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]

    Apparent clearance of CKD-501 at steady state

  14. (Part 2) Vdss/F 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]

    Apparent volume of distribution of CKD-501 at steady state

  15. (Part 2) Fluctuation[(Css,max-Css,min)/Css,av] 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]

    Fluctuation concentration of CKD-501 at steady state

  16. (Part 2) Swing[(Css,max-Css,min)/Css,min] 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]

    Swing concentration of CKD-501 at steady state

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  1. 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)

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

  3. 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

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

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

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

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

  8. 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

  9. 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

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

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

  12. Patients with hepatic impairment

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

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

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

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

  17. Pregnant and lactating women

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chonbuk National University Hospital Jeonju Korea, Republic of

Sponsors and Collaborators

  • Chong Kun Dang Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT03616392
Other Study ID Numbers:
  • 19DDI18013
First Posted:
Aug 6, 2018
Last Update Posted:
Nov 19, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chong Kun Dang Pharmaceutical
Diabetes Mellitus, Type II
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 19, 2018