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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Open-label, Single Dose, 2-period, 2-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-375 Tablet With D387 Tablet in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03848637
• Other study ID #: 192BE18036
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 14, 2019
• Est. completion date: May 1, 2019

Study information

• Verified date: March 2019
• Source: Chong Kun Dang Pharmaceutical
• Contact: Kyung-Sang Yu, M.D.,Ph.D
• Phone: +82-2-2072-1920
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: May 1, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• CKD-375
Test drug
• D387
Reference drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration of Empagliflozin	Cmax of Empagliflozin	Time Frame: 0 hour ~ 48 hour after drug administration
Primary	Maximum plasma concentration of Metformin	Cmax of Metformin	Time Frame: 0 hour ~ 48 hour after drug administration
Primary	Area under the plasma concentration of Empagliflozin-time curve from time zero to time of last measurable concentration	AUClast of Empagliflozin	Time Frame: 0 hour ~ 48 hour after drug administration
Primary	Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration	AUClast of Metformin	Time Frame: 0 hour ~ 48 hour after drug administration
Secondary	Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity	AUCinf of Empagliflozin	0 hour ~ 48 hour after drug administration
Secondary	Area under the plasma concentration of Metformin-time curve from time zero to infinity	AUCinf of Metformin	0 hour ~ 48 hour after drug administration
Secondary	Time to reach maximum (peak) plasma concentration of Empagliflozin following drug administration	Tmax of Empagliflozin	0 hour ~ 48 hour after drug administration
Secondary	Time to reach maximum (peak) plasma concentration of Metformin following drug administration	Tmax of Metformin	0 hour ~ 48 hour after drug administration
Secondary	Half-life of Empagliflozin	t1/2 of Empagliflozin	0 hour ~ 48 hour after drug administration
Secondary	Half-life of Metformin	t1/2 of Metformin	0 hour ~ 48 hour after drug administration
Secondary	Apparent clearance of Empagliflozin	CL/F of Empagliflozin	0 hour ~ 48 hour after drug administration
Secondary	Apparent clearance of Metformin	CL/F of Metformin	0 hour ~ 48 hour after drug administration
Secondary	Apparent volume of distribution of Empagliflozin	Vd/F of Empagliflozin	0 hour ~ 48 hour after drug administration
Secondary	Apparent volume of distribution of Metformin	Vd/F of Metformin	0 hour ~ 48 hour after drug administration