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

Phase 1

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: CKD-370; Drug: D745

• Registration Number: NCT03849495
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-02
• Study Start: 2019-02-19
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Last Update Submitted: 2019-03-10
• Last Update Posted: 2019-03-12
• Primary Completion: 2019-03-17
• Study Completion: 2019-03-21

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, 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	D745	* Period 1: D745 * Period 2: CKD-370
Group A	CKD-370	* Period 1: D745 * Period 2: CKD-370
Group B	CKD-370	* Period 1: CKD-370 * Period 2: D745
Group B	D745	* Period 1: CKD-370 * Period 2: D745

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of