Status:
UNKNOWN
Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-370 and D745 in Healthy Adults
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
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
- 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
- History of clinically significant hepatic, renal, nervous, immune, respiratory, digestive, urinary, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
- 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
- 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 first IP dosing
- Not eligible to participate for the study at the discretion of Investigator
- Other exclusive inclusion criteria, as defined in the protocol
Key Trial Info
Start Date :
February 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 21 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03849495
Start Date
February 19 2019
End Date
March 21 2019
Last Update
March 12 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Seoul, South Korea