CKD-355 Drug-drug Interaction Study (CKD-355 DDI P1)

NCT03569579 | Completed Phase 1

• 1 other identifier: 179DDI18002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a pharmacokinetic drug interaction between D797 of D324 in healthy volunteers

Conditions

Central Nervous System Diseases

Outcome Measures

Primary Outcomes (2)

• AUCt of Memantine

  Area under the plasma concentration of Memantine versus time curve from time zero to time of last quantifiable concentration

  1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h

• Cmax of Memantine

  Maximum plasma concentration of Memantine

  1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h

Secondary Outcomes (5)

• AUCinf of Memantine

  1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h

• Tmax of Memantine

  1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h

• t1/2 of Memantine

  1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h

• CL/F of Memantine

  1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h

• Vd/F of Memantine

  1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h

Study Arms (2)

Group 1(Treatment A/Treatment B)

EXPERIMENTAL

Period 1: Treatment A(Memantine Tab. 10mg)\*2T, QD, PO. Period 2: Treatment B(Memantine Tab. 10mg)\*2T + Donepezil Tab. 10mg)\*1T, QD, PO. Each treatment period was separated by a washout period of at least 21 dyas.

Drug: Memantine Tab. 10mg; Drug: Memantine Tab. 10mg + Donepezil Tab. 10mg

Group 1(Treatment B/Treatment A)

EXPERIMENTAL

Period 1: Treatment B(Memantine Tab. 10mg)\*2T + Donepezil Tab. 10mg)\*1T, QD, PO. Period 2: Treatment A(Memantine Tab. 10mg)\*1T, QD, PO. Each treatment period was separated by a washout period of at least 21 dyas.

Drug: Memantine Tab. 10mg; Drug: Memantine Tab. 10mg + Donepezil Tab. 10mg

Interventions

Memantine Tab. 10mg DRUG

Memantine Tab. 10mg\* 2T/day, QD, PO

Also known as: Ebixa Tab. 10mg

Group 1(Treatment A/Treatment B); Group 1(Treatment B/Treatment A)

Memantine Tab. 10mg + Donepezil Tab. 10mg DRUG

Memantine Tab. 10mg\* 2T/day + Donepezil Tab. 10mg \* 1T/day, QD, PO

Also known as: Ebixa Tab. 10mg + Aricept Tab. 10mg

Group 1(Treatment A/Treatment B); Group 1(Treatment B/Treatment A)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A healthy adult whose age is over 19 years old when visiting for initial screening test
• Body mass index(BMI) between 17.5\~30.5 kg/m\^2 and the body weight must be over 55kg (Body mass index (BMI) = weight (kg) / height (m)\^2)
• A person with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
• Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc.
• The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs.
• The participants must have an ability and willingness to participate throughout the entire trials

You may not qualify if:

• A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nercous, or allergic(except subclinical seasonal allergies that is not treated at injecion) desease.
• Who had a gistory of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy)
• Who had following results after examination
• a. ALT or AST \> twice higher than normal value
• Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250 mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (!2%) (125 mL) = 12g)
• Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial.
• Whose blood pressure \< 100 or ≥140(systolic blood pressure) or \< 70 or ≥ 90(diastolic blood pressure)
• Who had a medical history of alcohol and drug abuses.
• Who had taken a drug that has a control of metabolic rate (activatioh or inhibithion) in 30 days before the first taking of clinical testing durg.
• Who smokes more than 10 eigarettes per day.
• Who took prescribed drugs or over-the-conuter durgs in 10 days before taking of very first clinical testing drug.
• Who participated in whole blood donation in 2 months before the first taking of clinical testing drugs or platelet donations in 1 month before the first taking to clinical testing drugs.
• Who has a potent to increase a danger by participating in the clinical trials or sho can interrupt interpretin test results by having serious or chronic medical and mental status or having issues in results of the screening examination.
• Who has a histroy of an extreme sensitivity of drugs that contain donepezil hydrochloride, piperidine derivatives, memantine hydrochloride drugs.
• Who has a serious heart failure or a congestive heart failure that must be drug-treated

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Central Nervous System Diseases

Interventions

Memantine; Donepezil

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Kyung-Ho Jang, Professor

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: June 26, 2018
• Study Start: April 16, 2018
• Primary Completion: May 21, 2018
• Study Completion: June 4, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

KR (1)