Clinical trial NCT03848637: The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-375
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-02-21
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum plasma concentration of Empagliflozin
timeFrame: Time Frame: 0 hour ~ 48 hour after drug administration
measure: Maximum plasma concentration of Metformin
timeFrame: Time Frame: 0 hour ~ 48 hour after drug administration
measure: Area under the plasma concentration of Empagliflozin-time curve from time zero to time of last measurable concentration
timeFrame: Time Frame: 0 hour ~ 48 hour after drug administration
measure: Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration
timeFrame: Time Frame: 0 hour ~ 48 hour after drug administration
Secondary outcomes:
measure: Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Area under the plasma concentration of Metformin-time curve from time zero to infinity
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Time to reach maximum (peak) plasma concentration of Empagliflozin following drug administration
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Time to reach maximum (peak) plasma concentration of Metformin following drug administration
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Half-life of Empagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Half-life of Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Apparent clearance of Empagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Apparent clearance of Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Apparent volume of distribution of Empagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Apparent volume of distribution of Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: