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

Alzheimer's Disease (AD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03802162
• Other study ID #: 179BE18029
• Status: Completed
• Phase: Phase 1
• Start date: February 15, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: October 2019
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease (AD)

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of D324	Max Concentration of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Primary	AUCt of D324	Area under the curve of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Primary	Cmax of D797	Max Concentration of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Primary	AUCt of D797	Area under the curve of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Secondary	Cmin of D324	Min Concentration of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Secondary	Cmin of D797	Min Concentration of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Secondary	Tmax of D324	Time of Max concentration of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Secondary	Tmax of D797	Time of Max concentration of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Secondary	t½ of D324	Half-life time of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Secondary	t½ of D797	Half-life time of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours