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A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355
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
Lead sponsor
Assets
CKD-355A / CKD-355B / D324 / D797
Listed sites
1
Recruiting sites
-
Enrollment
60
actual
Study population
Alzheimer’s disease
Key I/E criterion
•Age 19-55
Primary endpoints
•Cmax of D324•AUCt of D324•Cmax of D797
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Healthy adult older than 19 years and less than 55 years at the time of screening
2. BMI 18.5~29.9 kg/m2 and body weight more than 50kg
3. 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
4. Subjects who sign on an informed consent form willingly
Exclusion criteria
1. Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease.
2. Subjects who have acute disease within 28 days prior to the first administration
3. Subjects who have history that may affect the ADME
4. Subjects who have clinically significant chronic disease
5. Women who are nursing, pregnant or positive on pregnancy test
6. Subjects who have clinically significant allergic diseases
7. Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
8. Subjects who are known to be hypersensitive to the drug or its components
9. Subjects who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody)
10. Subjects with creatinine clearance <60 ml / min
11. Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range
12. 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
13. Subjects who can not eat standard meals provided by the institution.
14. Subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days
15. Subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration
16. 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)
17. Subjects who participate in the other clinical trial within 90 days prior to the first administration
18. Subjects who have a history of regular alcohol(alcohol>210g/week) or caffeine(caffeine>5 cups/day)
19. Subjects who smokes more than 10 cigarettes per day within 3 months or cannot discontinue smoking during the clinical trial
20. Subjects who is determined unsuitable to participate in this clinical trial by the investigator
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
6 endpointsCmax of D324
Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
concentration, descriptive
Cmax of D797
Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
concentration, descriptive
Tmax of D324
Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
concentration, descriptive
Tmax of D797
Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
concentration, descriptive
t½ of D324
Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
concentration, descriptive
t½ of D797
Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
concentration, descriptive
Other (unclassified)
4 endpointsAUCt of D324
Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
descriptive
AUCt of D797
Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
descriptive
Cmin of D324
Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
concentration, descriptive
Cmin of D797
Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
concentration, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.