Clinical Trials/NCT03738449

NCT03738449

Completed

Phase 1

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D484 Under Fed Condition in Healthy Adults

Chong Kun Dang Pharmaceutical1 site in 1 country23 target enrollmentJanuary 8, 2019

ConditionsType 2 Diabetes Mellitus

InterventionsCKD-387 D484

DrugsCKD-387 D484

Overview

Phase: Phase 1
Intervention: CKD-387
Conditions: Type 2 Diabetes Mellitus
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 23
Locations: 1
Primary Endpoint: Maximum plasma concentration of Metformin
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 8, 2019

End Date

January 24, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adults aged 19 to 55 years
•Females must be menopause or surgical infertility
•Signed informed consent form
•Other inclusion criteria, as defined in the protocol

Exclusion Criteria

•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

Arms & Interventions

Group 1

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

Intervention: CKD-387

Group 1

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

Intervention: D484

Group 2

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

Intervention: CKD-387

Group 2

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

Intervention: D484

Outcomes

Primary Outcomes

Maximum plasma concentration of Metformin

Time Frame: 0 hour ~ 48 hour after drug administration

Cmax of Metformin

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

Time Frame: 0 hour ~ 48 hour after drug administration

AUClast of Metformin

Secondary Outcomes

Area under the plasma concentration of Metformin-time curve from time zero to infinity(0 hour ~ 48 hour after drug administration)
Apparent clearance of Metformin(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 volume of distribution of Metformin(0 hour ~ 48 hour after drug administration)