Status:
COMPLETED
A Study to Investigate the PK and Safety of CKD-393
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Type II Diabetes
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
A clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393
Detailed Description
A randomized, open-label, single-dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393 and co-administration of CKD-501, D759 and H...
Eligibility Criteria
Inclusion
- \[Inclusion Criteria\]
- Between 19 aged and 50 aged healthy adult
- Body weight more than 55kg for male, more than 50kg for female
- Body Mass Index over 18.5kg/m2 and under 27.0kg/m2
- if female, the subject must satisfy more than one of the following:
- subject who have reached menopause (no natural menstruation for at least 2 years.)
- subject who is surgically infertile(hysterectomy or bilateral salpingo-oophorectomy, tubal ligation, or in infertile state under other method)
- \[Exclusion Criteria\]
- Subject who is currently with or have diagnosed with clinically significant hepatobiliary(severe hepatopathy, etc.), kidney(severe nephropathy, etc.), neurological, immunologic, respiratory, urinary, gastrointestinal endocrinological(diabetic ketoacidosis, diabetic coma, etc.), hematological, oncological, cardiovascular(heart failure, etc.) or metal illness
- Subject with one of the following laboratory test results
- AST, ALT \> UNLx1.5
- eGRF \< 60 ml/min/1.73 m2 (MDRD formula)
- immuno-serology test results in positive
- Systolic blood pressure \> 150mmHg or \<90mmHg, Diastolic blood pressure \>100mmHg or \<50mmHg
- Subject who has history of the following and the history may affect safety of the subject or result of this study
- History of any prescription drug or herbal medicine within 14 days before first administration investigational products
- History of any non-prescription drug including health food, vitamin within 7 days before first administration investigational products
- History of drug-metabolizing induction/inhibition enzyme such as barbital
Exclusion
Key Trial Info
Start Date :
March 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04768673
Start Date
March 26 2021
End Date
April 27 2021
Last Update
August 2 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Severance Hospital
Seoul, Seodaemun-gu,, South Korea, 03722