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
Overview
- Phase
- Phase 1
- Intervention
- CKD-375
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 28
- Primary Endpoint
- Maximum plasma concentration of Empagliflozin
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adults aged 19 to 55 years
- •Females who are not pregnant or breastfeeding or who have surgical infertility
- •Signed informed consent form
- •Other inclusion criteria, as defined in the protocol
Exclusion Criteria
- •History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
- •Clinical laboratory test values are outside the accepted normal range at Screening
- •Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge.
- •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.
- •Participated in a clinical trial within 90 days prior to 1st IP dosing
- •Not eligible to participate for the study at the discretion of Investigator
- •Other exclusive inclusion criteria, as defined in the protocol
Arms & Interventions
Group 1
* Period 1: D387 (reference drug) * Period 2: CKD-387 (test drug)
Intervention: CKD-375
Group 1
* Period 1: D387 (reference drug) * Period 2: CKD-387 (test drug)
Intervention: D387
Group 2
* Period 1: CKD-387 (test drug) * Period 2: D387 (reference drug)
Intervention: CKD-375
Group 2
* Period 1: CKD-387 (test drug) * Period 2: D387 (reference drug)
Intervention: D387
Outcomes
Primary Outcomes
Maximum plasma concentration of Empagliflozin
Time Frame: Time Frame: 0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin
Maximum plasma concentration of Metformin
Time Frame: Time Frame: 0 hour ~ 48 hour after drug administration
Cmax of Metformin
Area under the plasma concentration of Empagliflozin-time curve from time zero to time of last measurable concentration
Time Frame: Time Frame: 0 hour ~ 48 hour after drug administration
AUClast of Empagliflozin
Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration
Time Frame: Time Frame: 0 hour ~ 48 hour after drug administration
AUClast of Metformin
Secondary Outcomes
- Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity(0 hour ~ 48 hour after drug administration)
- Area under the plasma concentration of Metformin-time curve from time zero to infinity(0 hour ~ 48 hour after drug administration)
- Time to reach maximum (peak) plasma concentration of Empagliflozin following drug administration(0 hour ~ 48 hour after drug administration)
- Half-life of Empagliflozin(0 hour ~ 48 hour after drug administration)
- Time to reach maximum (peak) plasma concentration of Metformin following drug administration(0 hour ~ 48 hour after drug administration)
- Half-life of Metformin(0 hour ~ 48 hour after drug administration)
- Apparent clearance of Empagliflozin(0 hour ~ 48 hour after drug administration)
- Apparent clearance of Metformin(0 hour ~ 48 hour after drug administration)
- Apparent volume of distribution of Empagliflozin(0 hour ~ 48 hour after drug administration)
- Apparent volume of distribution of Metformin(0 hour ~ 48 hour after drug administration)