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The purpose of this study is to evaluate a pharmacokinetic drug interaction between D797 of D324 in healthy volunteers
To healthy subjects of twenty(20), following treatments are administered dosing in each period and wash-out period is a minimum of 21 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine Tab. 10mg | Drug | Memantine Tab. 10mg* 2T/day, QD, PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of Memantine | Area under the plasma concentration of Memantine versus time curve from time zero to time infinity | 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h |
| Tmax of Memantine |
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Inclusion Criteria:
Exclusion Criteria:
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
Who has a Pregnant or potentially pregnant.
Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders.
A patient with severe hepatopathy
A patient with moderate nephropathy.
A person who is not determined unsuitable to participate in this test by the researchers.
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Ho Jang, Professor | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | South Korea |
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| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Memantine Tab. 10mg + Donepezil Tab. 10mg | Drug | Memantine Tab. 10mg* 2T/day + Donepezil Tab. 10mg * 1T/day, QD, PO |
|
|
Time to maximum concentration of of Memantine
| 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h |
| t1/2 of Memantine | Apparent terminal half-life of Memantine | 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h |
| CL/F of Memantine | Total body clearance of Memantine | 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h |
| Vd/F of Memantine | Apparent volume of distribution of Memantine | 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |