Pharmacokinetics, Safety and Tolerability of CKD-387 10/500mg BE Phase1

November 6, 2019 updated by: Chong Kun Dang Pharmaceutical

An Open-label, Rendomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-387 in Healthy Subjects.

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-387

Study Overview

Detailed Description

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-387 in helalthy subjects.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Seongbuk-Gu
      • Seoul, Seongbuk-Gu, Korea, Republic of
        • Korea University Anam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy adult older than 19 years and less than 45 years at the time of screening.
  2. BMI 18.5~29.9 kg/m2 and body weight more than 50kg.
  3. Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to one months after the last investigational product and not to provide sperm for men.
  4. Subjects who sign on an informed consent form willingly.

Exclusion Criteria:

  1. Subjects who have a clinically significant disease or medical history such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nervous and mental disease.
  2. Subjects who have acute disease within 28 days prior to the first administration.
  3. Subjects who have history that may affect the ADME.
  4. Subjects who have medical history or medical abuse history of hypersensitivity from SGLT inhibitors or Biguanides including Metformin or other medications(Aspirin, Antibiotics etc.).
  5. Subjects who have clinically significant chronic disease.
  6. Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose mal-absorption.
  7. Subjects whose laboratory test result are same as below;

    • AST,ALT > UNL(Upper Normal Limit)x3
    • Fasting glucose level out of 70-125mg/dl
    • Creatinine clearance is lower than 80mL/min which is calcuated by Cockcroft-Gault formulation.
    • QT>450msec
    • Positive urine hCG(female).
  8. Subjects whoes blood pressure exceeds out of normal range as below at screening.

    • SBP : over 100mmHg, under 160mmHg
    • DBP : over 60mmHg, under 100mmHg
  9. Subjects who have been found to be positive in serological tests(HBs antigen, HCV antibody and HIV antibody).
  10. Subjects who took ETC(Ethical Drug), oriental medicine within 2 weeks prior to the first administration of investigational products.
  11. Subjects who took OTC(Over-the-counter Drug, including korean galenical drug) within 10 days prior to the first administration of investigational products.
  12. Subjects who have allergic disease which has clinical significance(But, light allergic rhinitis and ligth allergic dermatitis which do not need medication is exceptional).
  13. Subjects who can not eat standard meals provided by the institution.
  14. Subjects who donated whole blood within 60 days, donated the blood components within 20 days prior to the first administration of investigational products.
  15. Subjects who received blood transfusion within 30 days prior to the first administration of investigational products.
  16. Subjects who were participated in the other clinical trial within 90 days prior to the first administration of investigational products.
  17. Subjects who took medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 6months prior to the first administration of investigational products.
  18. Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days prior to the first administration of investigational products. (Ingestion of grapefruit juice>1L/day or Caffein>5Cups/day).
  19. Subjects who have took regular alcohol(alcohol>30g/day) prior to the first administration of investigational products.
  20. Subjects who smoked more than 10 cigarettes per day prior 3months to the first administration of investigational products or cannot discontinue smoking during the clinical trial.
  21. Subjects who is determined unsuitable to participate in this clinical trial by the investigator.
  22. Lactating Women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PartA, Treatment-1
Period 1 : Reference drug Period 2 : Test drug
Once a day. Under fasting condition
Other Names:
  • PartA, Test(CKD-387 10/500mg)
Experimental: PartA, Treatment-2
Period 1 : Test drug Period 2 : Reference drug
Once a day. Under fasting condition
Other Names:
  • PartA, Test(CKD-387 10/500mg)
Experimental: PartB, Treatment-1
Period 1 : Reference drug Period 2 : Test drug
Once a day. Under fed condition
Other Names:
  • PartB, Test(CKD-387 10/500mg)
Experimental: PartB, Treatment-2
Period 1 : Test drug Period 2 : Reference drug
Once a day. Under fed condition
Other Names:
  • PartB, Test(CKD-387 10/500mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A : Cmax under fasting condition
Time Frame: 0(predose)~48 hours
Maximum concentration of the dapagliflozin
0(predose)~48 hours
Part A : Cmax under fasting condition
Time Frame: 0(predose)~48 hours
Maximum concentration of the metformin
0(predose)~48 hours
Part A : AUClast under fasting condition
Time Frame: 0(predose)~48 hours
Area Under Curve(last) of the dapagliflozin
0(predose)~48 hours
Part A : AUClast under fasting condition
Time Frame: 0(predose)~48 hours
Area Under Curve(last) of the metformin
0(predose)~48 hours
Part B : Cmax under fed condition
Time Frame: 0(predose)~48 hours
Maximum concentration of the metformin
0(predose)~48 hours
Part B : AUClast under fed condition
Time Frame: 0(predose)~48 hours
Area Under Curve(last) of the metformin
0(predose)~48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A : AUCinf under fasting condition
Time Frame: 0(predose)~48 hours
Area Under Curve(infinit) of the dapagliflozin
0(predose)~48 hours
Part A : AUCinf under fasting condition
Time Frame: 0(predose)~48 hours
Area Under Curve(infinit) of the metformin
0(predose)~48 hours
Part A : Tmax under fasting condition
Time Frame: 0(predose)~48 hours
Time of maximum concentration of the dapagliflozin
0(predose)~48 hours
Part A : Tmax under fasting condition
Time Frame: 0(predose)~48 hours
Time of maximum concentration of the metformin
0(predose)~48 hours
Part A : t1/2 under fasting condition
Time Frame: 0(predose)~48 hours
Half life of the dapagliflozin
0(predose)~48 hours
Part A : t1/2 under fasting condition
Time Frame: 0(predose)~48 hours
Half life of the metformin
0(predose)~48 hours
Part B : AUCinf under fed condition
Time Frame: 0(predose)~48 hours
Area Under Curve(infinit) of the metformin
0(predose)~48 hours
Part B : Tmax under fed condition
Time Frame: 0(predose)~48 hours
Time of Maximum concentration of the metformin
0(predose)~48 hours
Part B : t1/2 under fed condition
Time Frame: 0(predose)~48 hours
Half life of the metformin
0(predose)~48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ji-Young Park, M.D, Ph.D, Korea University Anam Hospital / Seoul, Seongbuk-Gu, South Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2019

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

October 2, 2019

Study Registration Dates

First Submitted

November 6, 2019

First Submitted That Met QC Criteria

November 6, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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