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

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: CKD-375; Drug: D387

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kyung-Sang Yu, M.D.,Ph.D; Phone Number: +82-2-2072-1920
• Study Contact Backup: Name: Soyoung Lee, Pharmacist; Phone Number: +82-2-740-8872; Email: sylee0829@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1; Period 1: D387 (reference drug); Period 2: CKD-387 (test drug)	Drug: CKD-375; Test drug; Drug: D387; Reference drug
EXPERIMENTAL: Group 2; Period 1: CKD-387 (test drug); Period 2: D387 (reference drug)	Drug: CKD-375; Test drug; Drug: D387; Reference drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration of Empagliflozin	Cmax of Empagliflozin	Time Frame: 0 hour ~ 48 hour after drug administration
Maximum plasma concentration of Metformin	Cmax of Metformin	Time Frame: 0 hour ~ 48 hour after drug administration
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration of Metformin-time curve from time zero to infinity	AUCinf of Metformin	0 hour ~ 48 hour after drug administration
Time to reach maximum (peak) plasma concentration of Metformin following drug administration	Tmax of Metformin	0 hour ~ 48 hour after drug administration
Half-life of Metformin	t1/2 of Metformin	0 hour ~ 48 hour after drug administration
Apparent clearance of Metformin	CL/F of Metformin	0 hour ~ 48 hour after drug administration
Apparent volume of distribution of Metformin	Vd/F of Metformin	0 hour ~ 48 hour after drug administration
Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity	AUCinf of Empagliflozin	0 hour ~ 48 hour after drug administration
Time to reach maximum (peak) plasma concentration of Empagliflozin following drug administration	Tmax of Empagliflozin	0 hour ~ 48 hour after drug administration
Half-life of Empagliflozin	t1/2 of Empagliflozin	0 hour ~ 48 hour after drug administration
Apparent clearance of Empagliflozin	CL/F of Empagliflozin	0 hour ~ 48 hour after drug administration
Apparent volume of distribution of Empagliflozin	Vd/F of Empagliflozin	0 hour ~ 48 hour after drug administration

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 14, 2019
• Primary Completion (ANTICIPATED): April 24, 2019
• Study Completion (ANTICIPATED): May 1, 2019

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (ACTUAL): February 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 192BE18036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No