A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355
NCT ID: NCT03802162
Last Updated: 2019-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2019-02-15
2019-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CKD-355 Drug-drug Interaction Study (CKD-355 DDI P1)
NCT03569579
Evaluate the Safety and Efficacy of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's Disease
NCT03790982
Safety, Tolerability, and Pharmacokinetics of ABT-354 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
NCT01908010
Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856
NCT05783830
Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer
NCT02553928
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CKD-355A
CKD-355A (D797/Memantine HCl 20mg)
once a day
CKD-355B
CKD-355B (D797/Memantine HCl 20mg)
once a day
D797, D324
D797
once a day
D324 (Memantine HCl 10mg)
twice a day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CKD-355A (D797/Memantine HCl 20mg)
once a day
CKD-355B (D797/Memantine HCl 20mg)
once a day
D797
once a day
D324 (Memantine HCl 10mg)
twice a day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
19 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Korea University Anam Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
179BE18029
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.