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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BPDO-1603

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06121
    • Hyundaipharm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BPDO-1603; 1 tablet contains memantine 20mg/donepezil 10mg	Drug: BPDO-1603; donepezil/mematine
Active Comparator: BPDO-16031,BPDO-16033; 1 tablet memantine 20mg and 1 tablet donepezil 10mg	Drug: BPDO-1603; donepezil/mematine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of memantine and donpezil	pharmacokinetic properties	from baseline to day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUClast of memantine and donpezil	pharmacokinetic properties	from baseline to day 10

Collaborators and Investigators

• Sponsor: Hyundai Pharm

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2022
• Primary Completion (Actual): February 21, 2023
• Study Completion (Actual): March 14, 2023

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 26, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: March 26, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Alzheimer's disease, Dementia
• Other Study ID Numbers: HT-007-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No