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

Phase 1

• Conditions: Type2 Diabetes Mellitus
• Interventions: Drug: CKD-387; Drug: D635

• Registration Number: NCT03849261
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-14
• Status Verified: 2019-02
• Primary Completion: 2019-02-01
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-20
• Last Update Submitted: 2019-02-20
• Study First Posted: 2019-02-21
• Last Update Posted: 2019-02-21
• Study Completion: 2019-02-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

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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

   • 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	CKD-387	* Period 1: D635 * Period 2: CKD-387
Group 1	D635	* Period 1: D635 * Period 2: CKD-387
Group 2	CKD-387	* Period 1: CKD-387 * Period 2: D635
Group 2	D635	* Period 1: CKD-387 * Period 2: D635

Primary Outcome Measures

Name	Time	Method
Cmax of Metformin	0 hour ~ 48 hour after drug administration	Maximum plasma concentration of Metformin
AUClast of Dapagliflozin	0 hour ~ 48 hour after drug administration	Area under the plasma concentration-time curve to last concentration of Dapagliflozin
AUClast of Metformin	0 hour ~ 48 hour after drug administration	Area under the plasma concentration-time curve to last concentration of Metformin
Cmax of Dapagliflozin	0 hour ~ 48 hour after drug administration	Maximum plasma concentration of Dapagliflozin

Secondary Outcome Measures

Name	Time	Method
AUCinf of Dapagliflozin	0 hour ~ 48 hour after drug administration	Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin
AUCinf of Metformin	0 hour ~ 48 hour after drug administration	Area under the plasma concentration-time curve from zero to infinity concentration of Metformin
Tmax of Dapagliflozin	0 hour ~ 48 hour after drug administration	Time to maximum plasma concentration of Dapagliflozin
Tmax of Metformin	0 hour ~ 48 hour after drug administration	Time to maximum plasma concentration of Metformin
T1/2 of Dapagliflozin	0 hour ~ 48 hour after drug administration	Half-life of Dapagliflozin
T1/2 of Metformin	0 hour ~ 48 hour after drug administration	Half-life of Metformin
Vd/F of Dapagliflozin	0 hour ~ 48 hour after drug administration	Apparent volume of distribution of Dapagliflozin
Vd/F of Metformin	0 hour ~ 48 hour after drug administration	Apparent volume of distribution of Metformin
CL/F of Dapagliflozin	0 hour ~ 48 hour after drug administration	Apparent clearance of Dapagliflozin
CL/F of Metformin	0 hour ~ 48 hour after drug administration	Apparent clearance of Metformin

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of