Pharmacokinetics and Safety/Tolerability Profile of CKD-379

Chong Kun Dang Pharmaceutical24 enrolled

Overview

A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination

A randomized, open-label, single dose, 3-period, 6-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type II Diabetes Mellitus

Interventions

CKD-379 IDRUG

1 tablet administration under fed condition

CKD-379 IIDRUG

1 tablet administration under fed condition

D759+D745+D150DRUG

3 tablet coadministration under fed condition

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Between 19 aged and 50 aged in healthy adult * 50.0kg ≤ Body weight ≤ 90.0kg and 18.0kg/m2 ≤ body mass index (BMI) ≤ 27.0kg/m2 Exclusion Criteria: * Have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis ect.), hematological system, cardiovascular system(heart failure, Torsades de pointes etc.), mental illness * Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis * Have a gastrointestinal disease(Crohn's disease, ulcer ect.) history that can effect drug absorption or surgery * Those who are pregnant or breastfeeding * Those who are deemed inappropriate to participate in clinical trial by investigators

Locations (1)

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Outcomes

Primary Outcomes

Cmax

Maximum plasma concentration of the drug

Time frame: 0~48hours

AUClast

Area under the concentration-time curve from the time of dosing to the last measurable concentration

Time frame: 0~48hours

Data from ClinicalTrials.gov

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