The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-387 Under Fed Condition

NCT03738449 | Completed Phase 1

• 1 other identifier: 184BE18014
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D484 under fed condition in healthy adults.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration of Metformin

  Cmax of Metformin

  0 hour ~ 48 hour after drug administration

• Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration

  AUClast of Metformin

  0 hour ~ 48 hour after drug administration

Secondary Outcomes (5)

• Area under the plasma concentration of Metformin-time curve from time zero to infinity

  0 hour ~ 48 hour after drug administration

• Time to reach maximum (peak) plasma concentration of Metformin following drug administration

  0 hour ~ 48 hour after drug administration

• Half-life of Metformin

  0 hour ~ 48 hour after drug administration

• Apparent clearance of Metformin

  0 hour ~ 48 hour after drug administration

• Apparent volume of distribution of Metformin

  0 hour ~ 48 hour after drug administration

Study Arms (2)

Group 1

EXPERIMENTAL

* Period 1: D484 * Period 2: CKD-387

Drug: CKD-387; Drug: D484

Group 2

EXPERIMENTAL

* Period 1: CKD-387 * Period 2: D484

Drug: CKD-387; Drug: D484

Interventions

CKD-387 DRUG

Test drug

Group 1; Group 2

D484 DRUG

reference drug

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 19 to 55 years
• Females must be menopause or surgical infertility
• Signed informed consent form

You may not qualify if:

• History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
• Clinical laboratory test values are outside the accepted normal range at Screening
• aspartate aminotransferase(AST), alanine aminotransferase(ALT) \> 1.25 times the upper limit of the normal range
• Total Bilirubin \> 1.5 times the upper limit of the normal range
• creatine phosphokinase(CPK) \> 1.5 times the upper limit of the normal range
• estimated Glomerular Filtration Rate(eGFR, MDRD\* formula) \< 60 mL/min/1.73m2 (\*MDRD: Modification of Diet in Renal Disease)
• Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis
• systolic blood pressure(SBP) ≥ 150 mmHg or \< 90 mmHg, diastolic blood pressure(DBP) \> 100 mmHg or \< 50 mmHg
• Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization
• Participated in a clinical trial within 90 days prior to 1st IP dosing
• Not eligible to participate for the study at the discretion of Investigator

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Min Soo Park, Ph.D. M.D.

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 13, 2018
• Study Start: January 8, 2019
• Primary Completion: January 18, 2019
• Study Completion: January 24, 2019
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

KR (1)