The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-375

Phase 1

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: CKD-375; Drug: D387

• Registration Number: NCT03848637
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-375 and D387 in healthy adults.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-06
• Study Start: 2019-04-14
• Primary Completion: 2019-04-24
• Study Completion: 2019-05-01

Recruitment & Eligibility

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

Inclusion Criteria

1. Healthy adults aged 19 to 55 years
2. Females who are not pregnant or breastfeeding or who have surgical infertility
3. Signed informed consent form
4. Other inclusion criteria, as defined in the protocol

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Exclusion Criteria

1. History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
2. Clinical laboratory test values are outside the accepted normal range at Screening
3. Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge.
4. Subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first IP dosing to the last discharge.
5. Participated in a clinical trial within 90 days prior to 1st IP dosing
6. Not eligible to participate for the study at the discretion of Investigator
7. Other exclusive inclusion 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	D387	* Period 1: CKD-387 (test drug) * Period 2: D387 (reference drug)
Group 1	D387	* Period 1: D387 (reference drug) * Period 2: CKD-387 (test drug)
Group 2	CKD-375	* Period 1: CKD-387 (test drug) * Period 2: D387 (reference drug)
Group 1	CKD-375	* Period 1: D387 (reference drug) * Period 2: CKD-387 (test drug)

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration of Empagliflozin	Time Frame: 0 hour ~ 48 hour after drug administration	Cmax of Empagliflozin
Maximum plasma concentration of Metformin	Time Frame: 0 hour ~ 48 hour after drug administration	Cmax of Metformin
Area under the plasma concentration of Empagliflozin-time curve from time zero to time of last measurable concentration	Time Frame: 0 hour ~ 48 hour after drug administration	AUClast of Empagliflozin
Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration	Time Frame: 0 hour ~ 48 hour after drug administration	AUClast of Metformin

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity	0 hour ~ 48 hour after drug administration	AUCinf of Empagliflozin
Area under the plasma concentration of Metformin-time curve from time zero to infinity	0 hour ~ 48 hour after drug administration	AUCinf of Metformin
Time to reach maximum (peak) plasma concentration of Empagliflozin following drug administration	0 hour ~ 48 hour after drug administration	Tmax of Empagliflozin
Half-life of Metformin	0 hour ~ 48 hour after drug administration	t1/2 of Metformin
Apparent clearance of Empagliflozin	0 hour ~ 48 hour after drug administration	CL/F of Empagliflozin
Apparent clearance of Metformin	0 hour ~ 48 hour after drug administration	CL/F of Metformin
Time to reach maximum (peak) plasma concentration of Metformin following drug administration	0 hour ~ 48 hour after drug administration	Tmax of Metformin
Half-life of Empagliflozin	0 hour ~ 48 hour after drug administration	t1/2 of Empagliflozin
Apparent volume of distribution of Empagliflozin	0 hour ~ 48 hour after drug administration	Vd/F of Empagliflozin
Apparent volume of distribution of Metformin	0 hour ~ 48 hour after drug administration	Vd/F of Metformin