Pharmacokinetics and Safety/Tolerability Profile of CKD-379

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Type II Diabetes Mellitus

Treatments: Drug: D759+D745+D150; Drug: CKD-379 I; Drug: CKD-379 II

Study type: Interventional

Funder types: Industry

Identifiers

NCT05452525

A125_01BE2204

Details and patient eligibility

About

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

Full 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

Enrollment: 24 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Period 1: Test drug(CKD-379 I) Period 2: Test drug(CKD-379 II) Period 3: Reference drug(D759+D745+D150)

Treatment:

Drug: CKD-379 II

Drug: CKD-379 I

Drug: D759+D745+D150

Sequence 2

Experimental group

Description:

Period 1: Test drug(CKD-379 I) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 II)

Treatment:

Drug: CKD-379 II

Drug: CKD-379 I

Drug: D759+D745+D150

Sequence 3

Experimental group

Description:

Period 1: Test drug(CKD-379 II) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 I)

Treatment:

Drug: CKD-379 II

Drug: CKD-379 I

Drug: D759+D745+D150

Sequence 4

Experimental group

Description:

Period 1: Test drug(CKD-379 II) Period 2: Test drug(CKD-379 I) Period 3: Reference drug(D759+D745+D150)

Treatment:

Drug: CKD-379 II

Drug: CKD-379 I

Drug: D759+D745+D150

Sequence 5

Experimental group

Description:

Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 I) Period 3: Test drug(CKD-379 II)

Treatment:

Drug: CKD-379 II

Drug: CKD-379 I

Drug: D759+D745+D150

Sequence 6

Experimental group

Description:

Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 II) Period 3: Test drug(CKD-379 I)

Treatment:

Drug: CKD-379 II

Drug: CKD-379 I

Drug: D759+D745+D150