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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BPDO-1603

• Registration Number: NCT05804279
• Lead Sponsor: Hyundai Pharm

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-28
• Primary Completion: 2023-02-21
• Status Verified: 2023-03
• Study Completion: 2023-03-14
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-26
• Last Update Submitted: 2023-03-26
• Study First Posted: 2023-04-07
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BPDO-1603	BPDO-1603	1 tablet contains memantine 20mg/donepezil 10mg
BPDO-16031,BPDO-16033	BPDO-1603	1 tablet memantine 20mg and 1 tablet donepezil 10mg

Primary Outcome Measures

Name	Time	Method
Cmax of memantine and donpezil	from baseline to day 10	pharmacokinetic properties

Secondary Outcome Measures

Name	Time	Method
AUClast of memantine and donpezil	from baseline to day 10	pharmacokinetic properties

Trial Locations

Locations (1)

Hyundaipharm; 🇰🇷 Seoul, Korea, Republic of