Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 in Healthy Adults

Type2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 in Healthy Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03849261
• Other study ID #: 184BE18026
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 14, 2019
• Est. completion date: February 22, 2019

Study information

• Verified date: February 2019
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 in healthy adults.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: February 22, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Healthy adults aged 19 to 55 years

2. Females must be menopause or 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

• aspartate aminotransferase(AST), alanine aminotransferase(ALT) > 1.25 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. Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization

4. Participated in a clinical trial within 90 days prior to 1st IP dosing

5. Not eligible to participate for the study at the discretion of Investigator

6. Other exclusive inclusion criteria, as defined in the protocol

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Drug:
• CKD-387
Test drug
• D635
Reference drug

Locations

Country	Name	City	State
Korea, Republic of	Severance 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	Cmax of Dapagliflozin	Maximum plasma concentration of Dapagliflozin	0 hour ~ 48 hour after drug administration
Primary	Cmax of Metformin	Maximum plasma concentration of Metformin	0 hour ~ 48 hour after drug administration
Primary	AUClast of Dapagliflozin	Area under the plasma concentration-time curve to last concentration of Dapagliflozin	0 hour ~ 48 hour after drug administration
Primary	AUClast of Metformin	Area under the plasma concentration-time curve to last concentration of Metformin	0 hour ~ 48 hour after drug administration
Secondary	AUCinf of Dapagliflozin	Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin	0 hour ~ 48 hour after drug administration
Secondary	AUCinf of Metformin	Area under the plasma concentration-time curve from zero to infinity concentration of Metformin	0 hour ~ 48 hour after drug administration
Secondary	Tmax of Dapagliflozin	Time to maximum plasma concentration of Dapagliflozin	0 hour ~ 48 hour after drug administration
Secondary	Tmax of Metformin	Time to maximum plasma concentration of Metformin	0 hour ~ 48 hour after drug administration
Secondary	T1/2 of Dapagliflozin	Half-life of Dapagliflozin	0 hour ~ 48 hour after drug administration
Secondary	T1/2 of Metformin	Half-life of Metformin	0 hour ~ 48 hour after drug administration
Secondary	Vd/F of Dapagliflozin	Apparent volume of distribution of Dapagliflozin	0 hour ~ 48 hour after drug administration
Secondary	Vd/F of Metformin	Apparent volume of distribution of Metformin	0 hour ~ 48 hour after drug administration
Secondary	CL/F of Dapagliflozin	Apparent clearance of Dapagliflozin	0 hour ~ 48 hour after drug administration
Secondary	CL/F of Metformin	Apparent clearance of Metformin	0 hour ~ 48 hour after drug administration