Pharmacokinetics and Safety/Tolerability Profile of CKD-379

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

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

Study Overview

• Status: Completed
• Conditions: Type II Diabetes Mellitus
• Intervention / Treatment: Drug: D759+D745+D150; Drug: CKD-379 I; Drug: CKD-379 II

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1: Test drug(CKD-379 I) Period 2: Test drug(CKD-379 II) Period 3: Reference drug(D759+D745+D150)	Drug: D759+D745+D150; 3 tablet coadministration under fed condition; Drug: CKD-379 I; 1 tablet administration under fed condition; Drug: CKD-379 II; 1 tablet administration under fed condition
Experimental: Sequence 2; Period 1: Test drug(CKD-379 I) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 II)	Drug: D759+D745+D150; 3 tablet coadministration under fed condition; Drug: CKD-379 I; 1 tablet administration under fed condition; Drug: CKD-379 II; 1 tablet administration under fed condition
Experimental: Sequence 3; Period 1: Test drug(CKD-379 II) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 I)	Drug: D759+D745+D150; 3 tablet coadministration under fed condition; Drug: CKD-379 I; 1 tablet administration under fed condition; Drug: CKD-379 II; 1 tablet administration under fed condition
Experimental: Sequence 4; Period 1: Test drug(CKD-379 II) Period 2: Test drug(CKD-379 I) Period 3: Reference drug(D759+D745+D150)	Drug: D759+D745+D150; 3 tablet coadministration under fed condition; Drug: CKD-379 I; 1 tablet administration under fed condition; Drug: CKD-379 II; 1 tablet administration under fed condition
Experimental: Sequence 5; Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 I) Period 3: Test drug(CKD-379 II)	Drug: D759+D745+D150; 3 tablet coadministration under fed condition; Drug: CKD-379 I; 1 tablet administration under fed condition; Drug: CKD-379 II; 1 tablet administration under fed condition
Experimental: Sequence 6; Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 II) Period 3: Test drug(CKD-379 I)	Drug: D759+D745+D150; 3 tablet coadministration under fed condition; Drug: CKD-379 I; 1 tablet administration under fed condition; Drug: CKD-379 II; 1 tablet administration under fed condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentration of the drug	0~48hours
AUClast	Area under the concentration-time curve from the time of dosing to the last measurable concentration	0~48hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Actual): August 27, 2022
• Study Completion (Actual): September 21, 2022

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: A125_01BE2204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No