A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions

Phase 1

Completed

• Conditions: Type2Diabetes
• Interventions: Drug: CKD-393(2); Drug: CKD-501, D759, D150, D029

• Registration Number: NCT05347576
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions

Detailed Description

A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-393(2) in healthy volunteers under fed conditions

Study Timeline

• Study Start: 2022-04-21
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-26
• Primary Completion: 2022-05-02
• Study Completion: 2022-05-09
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Healthy adult volunteers aged 19 ≤ ~ < 55-year-old.
2. Weight ≥55kg (man) or 45kg (woman), with calculated body mass index(BMI) of 17.5 ≤ ~ < 30.5 kg/m2.
3. Those who have no congenital diseases or chronic diseases within 3 years and have no abnormal symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.

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Exclusion Criteria

1. Those who have clinically significant disease or medical history of heart failure, Hepatopathy, Type 1 Diabetes, Diabetic ketoacidosis, Edema, Renal dysfunction, galactose intolerance, glucose-galactose malabsorption. And Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) during clinical trial.
2. Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of investigational drug.
3. Those who are pregnant or breastfeeding.
4. 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	CKD-501, D759, D150, D029	Period 1- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition Period 2- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition
sequence 1	CKD-501, D759, D150, D029	Period 1- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition Period 2- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition
sequence 2	CKD-393(2)	Period 1- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition Period 2- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition
sequence 1	CKD-393(2)	Period 1- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition Period 2- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition

Primary Outcome Measures

Name	Time	Method
AUCt	Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours	Area under the concentration-time curve from time zero to time
Cmax	Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours	Maximum plasma concentration of the drug

Trial Locations

Locations (1)

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