Study to Evaluate the Safety and Pharmacokinetics of CKD-379

Chong Kun Dang

Status and phase: Active, not recruiting; Phase 1

Conditions: Type II Diabetes Mellitus

Treatments: Drug: D759+D745+D029+D150; Drug: CKD-379

Study type: Interventional

Funder types: Industry

Identifiers

NCT05952219

A125_04BE2302

Details and patient eligibility

About

A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination

Full description

A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-379 in healthy volunteers under fed conditions

Enrollment: 32 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Between 19 aged and 50 aged in healthy adult
• 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2 and 50.0kg≤Body weight≤90.0kg

Exclusion criteria

• Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system
• Have a gastrointestinal disease(Crohn's disease, ulcer etc.) 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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32 participants in 2 patient groups

Sequence 1

Experimental group

Description:

Period 1: Reference drug(D759+D745+D029+D150) Period 2: Test drug(CKD-379)

Treatment:

Drug: D759+D745+D029+D150

Drug: CKD-379

Sequence 2

Experimental group

Description:

Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D029+D150)

Treatment:

Drug: D759+D745+D029+D150

Drug: CKD-379