Pharmacokinetics of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-28

Study Completion Date

2023-03-14

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BPDO-1603

1 tablet contains memantine 20mg/donepezil 10mg

Group Type EXPERIMENTAL

BPDO-1603

Intervention Type DRUG

donepezil/mematine

BPDO-16031,BPDO-16033

1 tablet memantine 20mg and 1 tablet donepezil 10mg

Group Type ACTIVE_COMPARATOR

BPDO-1603

Intervention Type DRUG

donepezil/mematine

Interventions

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BPDO-1603

donepezil/mematine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes