Study to Evaluate the Safety and Pharmacokinetics of CKD-379

Phase 1

Active, not recruiting

• Conditions: Type II Diabetes Mellitus
• Interventions: Drug: CKD-379; Drug: D759+D745+D029+D150

• Registration Number: NCT05952219
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2023-06-02
• Primary Completion: 2023-06-19
• Status Verified: 2023-07
• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-17
• Last Update Submitted: 2023-07-17
• Study First Posted: 2023-07-19
• Last Update Posted: 2023-07-19
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
AUCt	0~48hours	Maximum plasma concentration of the drug
Cmax	0~48hours	Area under the concentration-time curve from the time of dosing to the last measurable concentration

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of