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

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

• Status: Completed
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Drug: Part A, Reference (D635 10/500mg, Astrazeneca); Drug: Part B, Reference (D635 10/500mg, Astrazeneca)

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PartA, Treatment-1; Period 1 : Reference drug Period 2 : Test drug	Drug: Part A, Reference (D635 10/500mg, Astrazeneca); 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	Drug: Part A, Reference (D635 10/500mg, Astrazeneca); 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	Drug: Part B, Reference (D635 10/500mg, Astrazeneca); 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	Drug: Part B, Reference (D635 10/500mg, Astrazeneca); 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	Maximum concentration of the dapagliflozin	0(predose)~48 hours
Part A : Cmax under fasting condition	Maximum concentration of the metformin	0(predose)~48 hours
Part A : AUClast under fasting condition	Area Under Curve(last) of the dapagliflozin	0(predose)~48 hours
Part A : AUClast under fasting condition	Area Under Curve(last) of the metformin	0(predose)~48 hours
Part B : Cmax under fed condition	Maximum concentration of the metformin	0(predose)~48 hours
Part B : AUClast under fed condition	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	Area Under Curve(infinit) of the dapagliflozin	0(predose)~48 hours
Part A : AUCinf under fasting condition	Area Under Curve(infinit) of the metformin	0(predose)~48 hours
Part A : Tmax under fasting condition	Time of maximum concentration of the dapagliflozin	0(predose)~48 hours
Part A : Tmax under fasting condition	Time of maximum concentration of the metformin	0(predose)~48 hours
Part A : t1/2 under fasting condition	Half life of the dapagliflozin	0(predose)~48 hours
Part A : t1/2 under fasting condition	Half life of the metformin	0(predose)~48 hours
Part B : AUCinf under fed condition	Area Under Curve(infinit) of the metformin	0(predose)~48 hours
Part B : Tmax under fed condition	Time of Maximum concentration of the metformin	0(predose)~48 hours
Part B : t1/2 under fed condition	Half life of the metformin	0(predose)~48 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Ji-Young Park, M.D, Ph.D, Korea University Anam Hospital / Seoul, Seongbuk-Gu, South Korea

Study record dates

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

• Keywords: Type2 Diabetes Mellitus; CKD-387
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: A84_07BE1908

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No