Clinical Trials Logo
  1. Home
  2. Type II Diabetes Mellitus
  3. NCT05452525
  4. Details
NCT05452525 Clinical Trial

Pharmacokinetics and Safety/Tolerability Profile of CKD-379

Type II Diabetes Mellitus Clinical Trial

Official title:
A Randomized, Open-label, Single Dose, 3-period, 6-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05452525
Other study ID # A125_01BE2204
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 26, 2022
Est. completion date September 21, 2022

Study information
Verified date October 2022
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date September 21, 2022
Est. primary completion date August 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CKD-379 I
1 tablet administration under fed condition
• CKD-379 II
1 tablet administration under fed condition
• D759+D745+D150
3 tablet coadministration under fed condition

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Jongno-gu

Sponsors (1)
Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax Maximum plasma concentration of the drug 0~48hours
Primary AUClast Area under the concentration-time curve from the time of dosing to the last measurable concentration 0~48hours
See also
  Status Clinical Trial Phase
Completed NCT01952535 - A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral HMS5552 in Healthy Volunteers Phase 1
Completed NCT01196728 - Single-centre, Randomised, Double-blind, Placebo-controlled, Four-way Crossover Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Doses of CM3.1-AC100 in Patients With Type 2 Diabetes Phase 1
Terminated NCT00997152 - Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients Phase 2
Completed NCT02592421 - SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2 Phase 3
Completed NCT05544214 - Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects Phase 1
Completed NCT01969084 - The Effect of Linagliptin on Mitochondrial and Endothelial Function Phase 4
Terminated NCT01644201 - A Study Evaluating the Effects of a High Viscosity Non-starch Polysaccharide (PolyGlycopleX® - PGX®) on Glycemic Control, Cardiometabolic Risk Factors and Weight Loss in Overweight and Obese Type II Diabetics Phase 3
Completed NCT00995787 - Safety and Tolerability of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients Treated With Metformin and Sulfonylurea Phase 1
Completed NCT01020123 - Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients Phase 2
Completed NCT01505426 - A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients Phase 3
Completed NCT01262586 - Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device. Phase 3
Completed NCT00561171 - Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria Phase 2
Recruiting NCT03912363 - Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids N/A
Completed NCT01868646 - Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type II Diabetes Mellitus Phase 4
Not yet recruiting NCT06386328 - A Clinical Trial to Evaluate the Food Effect of CKD-378 Phase 1
Terminated NCT02749435 - A Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus N/A
Completed NCT00894868 - Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure Phase 4
Recruiting NCT01165190 - Effect of Pioglitazone on Mitochondrial Function in Muscle and Adipose Tissue in Humans N/A
Completed NCT01255085 - Yellow Pea Protein and Fibre and Short Term Food Intake N/A
Completed NCT02156349 - A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients. N/A