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Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D484 in Healthy Adults

Primary Purpose

Type II Diabetes

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-387
D484
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers between the ages of 19 and 55
  • Body weight ≥ 55kg for male, ≥ 50kg for female
  • Body mass index ≥ 18.5 kg/m2 and < 25.0 kg/m2
  • Females who are post-menopausal or underwent sterilization
  • Males who agreed to practice contraception until after 28 days of last intake Investigational product
  • Ability to provide written informed consent

Exclusion Criteria:

  • Subject with clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease and psychosis disorder
  • Subject who are weak in dehydration or clinically significant dehydration
  • IV injecting examination of radioactive-iodine substances within 48 hours prior to first IP administration
  • Subjects who have Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Subjects with history of gastrointestinal disease or surgery that may affect absorption of IP
  • Hypersensitive to dapagliflozin/metformin

  • At screening,

    • AST(Aspartate Transaminase), ALT(Alanine Transaminase) > UNL(upper normal limit)*1.25
    • Total Bilirubin > UNL(upper normal limit)*1.5, CPK > UNL(upper normal limit)*1.5
    • eGFR(estimated Glomerular Filtration Rate) < 60 mL/min/1.73m2(Modification of diet in renal Disease calculated)
    • Positive reaction on following tests: Hepatitis B, Hepatitis C, HIV(Human Immunodeficiency Virus) and syphilis
    • SBP(Systolic blood pressure) ≥ 150 mmHg or < 90 mmHg, DBP(Diastolic blood pressure) > 100 mmHg or < 50 mmHg
  • History of drug abuse or positive urine drug screening results
  • Women with pregnant, breast-feeding
  • Caffeine > 5 cups/day, Alcohol > 210 g/week, Smoker > 10 cigarettes /day or who are unable to stop caffeine intake, drinking alcohol and smoking until the last blood drawing for PK
  • Subject who took ethical drug/herbal compound within 14 days, over-the-counter drug/vitamin supplements within 7 days and depot injection/implantation within 30 days prior to the first IP administration
  • Subject who was enrolled in another clinical trial(including Bioequivalence study) and administered drugs within 90 days prior to the first IP administration
  • Subject with whole blood donation within 60 days or component blood donation within 30 days
  • Not eligible to participate for the study at the discretion of Investigator

Sites / Locations

  • Yonsei University Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Period 1: 1 tablet of reference drug(D484) Period 2: 1 tablet of test drug(CKD-387)

Period 1: 1 tablet of test drug(CKD-387) Period 2: 1 tablet of reference drug(D484)

Outcomes

Primary Outcome Measures

Cmax of Dapagliflozin
Maximum plasma concentration of Dapagliflozin
Cmax of Metformin
Maximum plasma concentration of Metformin
AUClast of Dapagliflozin
Area under the plasma concentration-time curve to last concentration of Dapagliflozin
AUClast of Metformin
Area under the plasma concentration-time curve to last concentration of Metformin

Secondary Outcome Measures

AUCinf of Dapagliflozin
Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin
AUCinf of Metformin
Area under the plasma concentration-time curve from zero to infinity concentration of Metformin
Tmax of Dapagliflozin
Time to maximum plasma concentration of Dapagliflozin
Tmax of Metformin
Time to maximum plasma concentration of Metformin
T1/2 of Dapagliflozin
Half-life of Dapagliflozin
T1/2 of Metformin
Half-life of Metformin
Vd/F of Dapagliflozin
Apparent volume of distribution of Dapagliflozin
Vd/F of Metformin
Apparent volume of distribution of Metformin
CL/F of Dapagliflozin
Apparent clearance of Dapagliflozin
CL/F of Metformin
Apparent clearance of Metformin

Full Information

First Posted
August 23, 2018
Last Updated
August 23, 2018
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03646799
Brief Title
Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D484 in Healthy Adults
Official Title
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2018 (Anticipated)
Primary Completion Date
September 9, 2018 (Anticipated)
Study Completion Date
September 14, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability after Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg in Healthy Adults

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Period 1: 1 tablet of reference drug(D484) Period 2: 1 tablet of test drug(CKD-387)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Period 1: 1 tablet of test drug(CKD-387) Period 2: 1 tablet of reference drug(D484)
Intervention Type
Drug
Intervention Name(s)
CKD-387
Intervention Description
test drug
Intervention Type
Drug
Intervention Name(s)
D484
Intervention Description
reference drug
Primary Outcome Measure Information:
Title
Cmax of Dapagliflozin
Description
Maximum plasma concentration of Dapagliflozin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Title
Cmax of Metformin
Description
Maximum plasma concentration of Metformin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Title
AUClast of Dapagliflozin
Description
Area under the plasma concentration-time curve to last concentration of Dapagliflozin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Title
AUClast of Metformin
Description
Area under the plasma concentration-time curve to last concentration of Metformin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Secondary Outcome Measure Information:
Title
AUCinf of Dapagliflozin
Description
Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Title
AUCinf of Metformin
Description
Area under the plasma concentration-time curve from zero to infinity concentration of Metformin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Title
Tmax of Dapagliflozin
Description
Time to maximum plasma concentration of Dapagliflozin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Title
Tmax of Metformin
Description
Time to maximum plasma concentration of Metformin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Title
T1/2 of Dapagliflozin
Description
Half-life of Dapagliflozin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Title
T1/2 of Metformin
Description
Half-life of Metformin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Title
Vd/F of Dapagliflozin
Description
Apparent volume of distribution of Dapagliflozin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Title
Vd/F of Metformin
Description
Apparent volume of distribution of Metformin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Title
CL/F of Dapagliflozin
Description
Apparent clearance of Dapagliflozin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Title
CL/F of Metformin
Description
Apparent clearance of Metformin
Time Frame
Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers between the ages of 19 and 55 Body weight ≥ 55kg for male, ≥ 50kg for female Body mass index ≥ 18.5 kg/m2 and < 25.0 kg/m2 Females who are post-menopausal or underwent sterilization Males who agreed to practice contraception until after 28 days of last intake Investigational product Ability to provide written informed consent Exclusion Criteria: Subject with clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease and psychosis disorder Subject who are weak in dehydration or clinically significant dehydration IV injecting examination of radioactive-iodine substances within 48 hours prior to first IP administration Subjects who have Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption Subjects with history of gastrointestinal disease or surgery that may affect absorption of IP Hypersensitive to dapagliflozin/metformin At screening, AST(Aspartate Transaminase), ALT(Alanine Transaminase) > UNL(upper normal limit)*1.25 Total Bilirubin > UNL(upper normal limit)*1.5, CPK > UNL(upper normal limit)*1.5 eGFR(estimated Glomerular Filtration Rate) < 60 mL/min/1.73m2(Modification of diet in renal Disease calculated) Positive reaction on following tests: Hepatitis B, Hepatitis C, HIV(Human Immunodeficiency Virus) and syphilis SBP(Systolic blood pressure) ≥ 150 mmHg or < 90 mmHg, DBP(Diastolic blood pressure) > 100 mmHg or < 50 mmHg History of drug abuse or positive urine drug screening results Women with pregnant, breast-feeding Caffeine > 5 cups/day, Alcohol > 210 g/week, Smoker > 10 cigarettes /day or who are unable to stop caffeine intake, drinking alcohol and smoking until the last blood drawing for PK Subject who took ethical drug/herbal compound within 14 days, over-the-counter drug/vitamin supplements within 7 days and depot injection/implantation within 30 days prior to the first IP administration Subject who was enrolled in another clinical trial(including Bioequivalence study) and administered drugs within 90 days prior to the first IP administration Subject with whole blood donation within 60 days or component blood donation within 30 days Not eligible to participate for the study at the discretion of Investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Soo Park, Ph.D.
Phone
82-2-2228-0270
Email
minspark@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Soo Park, Ph.D.
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Severance Hospital
City
Soeul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Soo Park, Ph.D. M.D
Phone
+82 2 2228 0400
Email
minspark@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Min Soo Park, Ph.D. M.D

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D484 in Healthy Adults

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