Status:
UNKNOWN
The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-375
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
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
- 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, 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
Key Trial Info
Start Date :
April 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03848637
Start Date
April 14 2019
End Date
May 1 2019
Last Update
March 6 2019
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