To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers

Phase 1

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: CKD-383(Fed); Drug: CKD-383(Fasted)

• Registration Number: NCT06492655
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers

Detailed Description

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

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study Start: 2024-07-04
• Study First Posted: 2024-07-09
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Healthy adults aged 19 to 54 years
• BMI measurement result is 18.0 kg/m2 to 30 kg/m2
• Written informed consent
• Other inclusion criteria, as defined in the protocol

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	CKD-383(Fed)	* Period 1: CKD-383 two tablets(Fasted) * Period 2: CKD-383 two tablets(Fed)
Group 1	CKD-383(Fed)	* Period 1: CKD-383 two tablets(Fed) * Period 2: CKD-383 two tablets(Fasted)
Group 1	CKD-383(Fasted)	* Period 1: CKD-383 two tablets(Fed) * Period 2: CKD-383 two tablets(Fasted)
Group 2	CKD-383(Fasted)	* Period 1: CKD-383 two tablets(Fasted) * Period 2: CKD-383 two tablets(Fed)

Primary Outcome Measures

Name	Time	Method
AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)	0 hour ~ 48 hour after drug administration	Pharmacokinetic characterization
Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)	0 hour ~ 48 hour after drug administration	Pharmacokinetic characterization