Skip to main content
OpenTrials
Completed

NCT Number: NCT05804279

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hyundaipharm

Seoul, 06121, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

BPDO-1603

Drug

donepezil/mematine

Primary outcomes

  1. Cmax of memantine and donpezil

    Time frame: from baseline to day 10

    pharmacokinetic properties

Secondary outcomes

  1. AUClast of memantine and donpezil

    Time frame: from baseline to day 10

    pharmacokinetic properties

Sponsors and collaborators

Lead sponsor

Hyundai Pharm

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2023
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.