NCT05804279

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 28, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
Last Updated

April 7, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 15, 2023

Last Update Submit

March 26, 2023

Conditions

Healthy

Keywords

Alzheimer's disease, Dementia

Outcome Measures

Primary Outcomes (1)

  • Cmax of memantine and donpezil

    pharmacokinetic properties

    from baseline to day 10

Secondary Outcomes (1)

  • AUClast of memantine and donpezil

    from baseline to day 10

Study Arms (2)

BPDO-1603

EXPERIMENTAL

1 tablet contains memantine 20mg/donepezil 10mg

Drug: BPDO-1603

BPDO-16031,BPDO-16033

ACTIVE COMPARATOR

1 tablet memantine 20mg and 1 tablet donepezil 10mg

Drug: BPDO-1603

Interventions

BPDO-1603DRUG

donepezil/mematine

BPDO-1603BPDO-16031,BPDO-16033

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 19 or older and 55 or less at the time of screening tests
  • Men weigh 55 kg or more and women weigh 50 kg or more
  • Those with a body mass index of 18.5 kg/m2 or more and less than 27.0 kg/m2

You may not qualify if:

  • 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.
  • A person who has a serious urinary tract infection due to renal tubular acidosis, etc. or has a history of history
  • Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hyundaipharm

Seoul, 06121, South Korea

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

April 7, 2023

Study Start

December 28, 2022

Primary Completion

February 21, 2023

Study Completion

March 14, 2023

Last Updated

April 7, 2023

Record last verified: 2023-03

Locations

KR(1)