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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05804279
• Other study ID #: HT-007-05
• Status: Completed
• Phase: Phase 1
• Start date: December 28, 2022
• Est. completion date: March 14, 2023

Study information

• Verified date: March 2023
• Source: Hyundai Pharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 14, 2023
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BPDO-1603
donepezil/mematine

Locations

Country	Name	City	State
Korea, Republic of	Hyundaipharm	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hyundai Pharm

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of memantine and donpezil	pharmacokinetic properties	from baseline to day 10
Secondary	AUClast of memantine and donpezil	pharmacokinetic properties	from baseline to day 10