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

Phase 1

Completed

• Conditions: Alzheimer's Disease (AD)
• Interventions: Drug: CKD-355A (D797/Memantine HCl 20mg); Drug: CKD-355B (D797/Memantine HCl 20mg); Drug: D797; Drug: D324 (Memantine HCl 10mg)

• Registration Number: NCT03802162
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Study Timeline

• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Study Start: 2019-02-15
• Primary Completion: 2019-05-10
• Study Completion: 2019-08-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CKD-355A	CKD-355A (D797/Memantine HCl 20mg)	-
CKD-355B	CKD-355B (D797/Memantine HCl 20mg)	-
D797, D324	D324 (Memantine HCl 10mg)	-
D797, D324	D797	-

Primary Outcome Measures

Name	Time	Method
Cmax of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours	Max Concentration of D324
AUCt of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours	Area under the curve of D797
AUCt of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours	Area under the curve of D324
Cmax of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours	Max Concentration of D797

Secondary Outcome Measures

Name	Time	Method
Tmax of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours	Time of Max concentration of D324
t½ of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours	Half-life time of D324
Cmin of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours	Min Concentration of D797
t½ of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours	Half-life time of D797
Cmin of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours	Min Concentration of D324
Tmax of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours	Time of Max concentration of D797

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of