Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-370 and D745 in Healthy Adults

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Open-label, Single Dose, Two-way Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-370 With D745 in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03849495
• Other study ID #: 191BE18033
• Status: Recruiting
• Phase: Phase 1
• Start date: February 19, 2019
• Est. completion date: March 21, 2019

Study information

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

Clinical Trial Summary

A randomized, open-label, single dose, two-way crossover study to compare the pharmacokinetics and safety/tolerability of CKD-370 with D745 in healthy volunteers

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: March 21, 2019
• Est. primary completion date: March 17, 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, digestive, urinary, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder

2. Clinical laboratory test values are outside the accepted normal range at Screening

• aspartate aminotransferase(AST), alanine aminotransferase(ALT) > 1.5 times the upper limit of the normal range

• Total Bilirubin > 1.5 times the upper limit of the normal range

• creatine phosphokinase(CPK) > 1.5 times the upper limit of the normal range

• estimated Glomerular Filtration Rate(eGFR, MDRD* formula) < 60 mL/min/1.73m2 (*MDRD: Modification of Diet in Renal Disease)

• Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis

• systolic blood pressure(SBP) = 150 mmHg or < 90 mmHg, diastolic blood pressure(DBP) > 100 mmHg or < 50 mmHg

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 first 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-370
Test drug
• D745
Reference drug

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast of Empagliflozin	Area under the plasma concentration-time curve to last concentration of Empagliflozin	0 hour ~ 48 hour after drug administration
Primary	Cmax of Empagliflozin	Maximum plasma concentration of Empagliflozin	0 hour ~ 48 hour after drug administration
Secondary	AUCinf of Empagliflozin	Area under the plasma concentration-time curve from zero to infinity concentration of Empagliflozin	0 hour ~ 48 hour after drug administration
Secondary	Tmax of Empagliflozin	Time to maximum plasma concentration of Empagliflozin	0 hour ~ 48 hour after drug administration
Secondary	T1/2 of Empagliflozin	Half-life of Empagliflozin	0 hour ~ 48 hour after drug administration
Secondary	CL/F of Empagliflozin	Apparent clearance of Empagliflozin	0 hour ~ 48 hour after drug administration
Secondary	Vd/F of Empagliflozin	Apparent volume of distribution of Empagliflozin	0 hour ~ 48 hour after drug administration