Status:
COMPLETED
A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Alzheimer's Disease (AD)
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-355.
Detailed Description
An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics, safety and tolerability of CKD-355 with D797 and D324 in healthy subjects
Eligibility Criteria
Inclusion
- Healthy adult older than 19 years and less than 55 years at the time of screening
- BMI 18.5\~29.9 kg/m2 and body weight more than 50kg
- Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to two months after the last investigational product and not to provide sperm for men
- Subjects who sign on an informed consent form willingly
Exclusion
- Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease.
- Subjects who have acute disease within 28 days prior to the first administration
- Subjects who have history that may affect the ADME
- Subjects who have clinically significant chronic disease
- Women who are nursing, pregnant or positive on pregnancy test
- Subjects who have clinically significant allergic diseases
- Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subjects who are known to be hypersensitive to the drug or its components
- Subjects who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody)
- Subjects with creatinine clearance \<60 ml / min
- Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range
- Subjects who taked ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 1 week prior to the first administration
- Subjects who can not eat standard meals provided by the institution.
- Subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days
- Subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration
- Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days before the first administration (eg, ingestion of grapefruit juice\>1 L / day)
- Subjects who participate in the other clinical trial within 90 days prior to the first administration
- Subjects who have a history of regular alcohol(alcohol\>210g/week) or caffeine(caffeine\>5 cups/day)
- Subjects who smokes more than 10 cigarettes per day within 3 months or cannot discontinue smoking during the clinical trial
- Subjects who is determined unsuitable to participate in this clinical trial by the investigator
Key Trial Info
Start Date :
February 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03802162
Start Date
February 15 2019
End Date
August 31 2019
Last Update
October 23 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Korea University Anam Hospital
Seoul, South Korea