A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease (AD)

Treatments: Drug: D797; Drug: CKD-355A (D797/Memantine HCl 20mg); Drug: CKD-355B (D797/Memantine HCl 20mg); Drug: D324 (Memantine HCl 10mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03802162

179BE18029

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-355.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

CKD-355A

Experimental group

Treatment:

Drug: CKD-355A (D797/Memantine HCl 20mg)

CKD-355B

Experimental group

Treatment:

Drug: CKD-355B (D797/Memantine HCl 20mg)

D797, D324

Active Comparator group

Treatment:

Drug: D324 (Memantine HCl 10mg)

Drug: D797