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

• Sponsor: Hyundai Pharm (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05804279
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 9.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BPDO-1603	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 28, 2022
• Actual Primary Completion Date: Feb 21, 2023
• Actual Study Completion Date: Mar 14, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cmax of memantine and donpezil [from baseline to day 10]

   pharmacokinetic properties

Secondary Outcome Measures

1. AUClast of memantine and donpezil [from baseline to day 10]

   pharmacokinetic properties

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hyundaipharm	Seoul		Korea, Republic of	06121

Sponsors and Collaborators

• Hyundai Pharm

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyundai Pharm
• ClinicalTrials.gov Identifier: NCT05804279
• Other Study ID Numbers: HT-007-05
• First Posted: Apr 7, 2023
• Last Update Posted: Apr 7, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hyundai Pharm: Alzheimer's disease, Dementia

Study Results

No Results Posted as of Apr 7, 2023