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

NCT04156685 | Completed Phase 1

• 1 other identifier: A84_07BE1908
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type2 Diabetes Mellitus

Keywords

Type2 Diabetes Mellitus; CKD-387

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Part A : AUCinf under fasting condition

  0(predose)~48 hours

• Part A : AUCinf under fasting condition

  0(predose)~48 hours

• Part A : Tmax under fasting condition

  0(predose)~48 hours

• Part A : Tmax under fasting condition

  0(predose)~48 hours

• Part A : t1/2 under fasting condition

  0(predose)~48 hours

Study Arms (4)

PartA, Treatment-1

EXPERIMENTAL

Period 1 : Reference drug Period 2 : Test drug

Drug: Part A, Reference (D635 10/500mg, Astrazeneca)

PartA, Treatment-2

EXPERIMENTAL

Period 1 : Test drug Period 2 : Reference drug

Drug: Part A, Reference (D635 10/500mg, Astrazeneca)

PartB, Treatment-1

EXPERIMENTAL

Period 1 : Reference drug Period 2 : Test drug

Drug: Part B, Reference (D635 10/500mg, Astrazeneca)

PartB, Treatment-2

EXPERIMENTAL

Period 1 : Test drug Period 2 : Reference drug

Drug: Part B, Reference (D635 10/500mg, Astrazeneca)

Interventions

Part A, Reference (D635 10/500mg, Astrazeneca) DRUG

Once a day. Under fasting condition

Also known as: PartA, Test(CKD-387 10/500mg)

PartA, Treatment-1

Part B, Reference (D635 10/500mg, Astrazeneca) DRUG

Once a day. Under fed condition

Also known as: PartB, Test(CKD-387 10/500mg)

PartB, Treatment-1

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult older than 19 years and less than 45 years at the time of screening.
• BMI 18.5\~29.9 kg/m2 and body weight more than 50kg.
• 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.
• Subjects who sign on an informed consent form willingly.

You may not qualify if:

• 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.
• Subjects who have acute disease within 28 days prior to the first administration.
• Subjects who have history that may affect the ADME.
• Subjects who have medical history or medical abuse history of hypersensitivity from SGLT inhibitors or Biguanides including Metformin or other medications(Aspirin, Antibiotics etc.).
• Subjects who have clinically significant chronic disease.
• Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose mal-absorption.
• 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).
• Subjects whoes blood pressure exceeds out of normal range as below at screening.
• SBP : over 100mmHg, under 160mmHg
• DBP : over 60mmHg, under 100mmHg

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, Seongbuk-Gu, South Korea

Location

Study Officials

• Ji-Young Park, M.D, Ph.D

  Korea University Anam Hospital / Seoul, Seongbuk-Gu, South Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 part, 2x2 crossover study

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 7, 2019
• Study Start: August 6, 2019
• Primary Completion: August 30, 2019
• Study Completion: October 2, 2019
• Last Updated: November 7, 2019

Record last verified: 2019-11

Locations

KR (1)