Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic of CKD-501, D745, and D150 for Healthy Subjects in Fed State.

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT06483243
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

This is a Randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of CKD-383 and the co-administration of CKD-501, D745, and D150 for healthy subjects in fed state

Detailed Description

Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 or 4 tablets in single dose: actual medication)

Study Timeline

• Study Start: 2024-04-04
• Primary Completion: 2024-04-29
• Study Completion: 2024-05-17
• Status Verified: 2024-06
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Healthy adults aged 19 to 65 years
• Based on screening, no congenital or chronic disease, who have no athological symptoms or findings(If necessary, EEG, ECG, chest and gastroscopy or gastrointestinal radiation, Examination)
• within 5 years prior to the start of the trial(Period 1 administration) of any clinically significant mental medical history
• Other inclusion criteria, as defined in the protocol

Read More

Exclusion Criteria

• who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period 1 administration)
• Other exclusive criteria, as defined in the protocol

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Cmax of Lobeglitazone, Empagliflozin, Metformin	0 hour ~ 48 hour after drug administration	Pharmacokinetic characterization
AUCt of Lobeglitazone, Empagliflozin, Metformin	0 hour ~ 48 hour after drug administration	Pharmacokinetic characterization

Secondary Outcome Measures

Name	Time	Method
CL/F of Lobeglitazone, Empagliflozin, Metformin	0 hour ~ 48 hour after drug administration	Pharmacokinetic characterization
AUC∞ of Lobeglitazone, Empagliflozin, Metformin	0 hour ~ 48 hour after drug administration	Pharmacokinetic characterization
Tmax of Lobeglitazone, Empagliflozin, Metformin	0 hour ~ 48 hour after drug administration	Pharmacokinetic characterization
T1/2 of Lobeglitazone, Empagliflozin, Metformin	0 hour ~ 48 hour after drug administration	Pharmacokinetic characterization
Vd/F of Lobeglitazone, Empagliflozin, Metformin	0 hour ~ 48 hour after drug administration	Pharmacokinetic characterization

Trial Locations

Locations (1)

Chung-Ang University Gwangmyeong Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of