Clinical trial NCT03849495: Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-370 and D745 in Healthy Adults
Official title: 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
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: 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


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, 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

Primary outcomes:
measure: AUClast of Empagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Cmax of Empagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
Secondary outcomes:
measure: AUCinf of Empagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Tmax of Empagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: T1/2 of Empagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: CL/F of Empagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Vd/F of Empagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung Sang Yu, Ph.D. M.D.
role: PRINCIPAL_INVESTIGATOR
References: