Healthy
Conditions
Keywords
Alzheimer's disease, Dementia
Brief summary
Pharmacokinetics and safety of BPDO-1603 or BPDO-16031 and BPDO-16033 administration in healthy adults. Randomized, open-label, single-dose, cross-over, Phase 1 study
Interventions
DRUGBPDO-1603
donepezil/mematine
Sponsors
Hyundai Pharm
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults aged 19 or older and 55 or less at the time of screening tests 2. Men weigh 55 kg or more and women weigh 50 kg or more 3. Those with a body mass index of 18.5 kg/m2 or more and less than 27.0 kg/m2
Exclusion criteria
1. Clinically significant active chronic diseases, hepatometer (severe liver disorder, etc.), kidney (severe kidney disorder, etc.), and nervous system (hepatorespiratory tract patients). Parkinson's disease, immune system, respiratory system (asthenia, obstructive pulmonary disease, etc.), urinary system, digestive system (digestive ulcer, etc.), endocrine system, blood/tumor, cardiovascular system (cardiac infarction, heart failure, uncontrolled hypertension, atrioventricular junction disorder, etc.), or have a history. 2. A person who has a serious urinary tract infection due to renal tubular acidosis, etc. or has a history of history 3. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of memantine and donpezil | from baseline to day 10 | pharmacokinetic properties |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUClast of memantine and donpezil | from baseline to day 10 | pharmacokinetic properties |
Countries
South Korea
Outcome results
None listed