## Protocol Section
### Identification Module
**NCT ID:** NCT05804279

**Brief Title:** Pharmacokinetics of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults

**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

#### Organization Study ID Info
**ID:** HT-007-05
#### Organization
**Class:** INDUSTRY
**Full Name:** Hyundai Pharm
### Status Module
#### Completion Date
**Date:** 2023-03-14

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-04-07

**Type:** ACTUAL

**Last Update Submit Date:** 2023-03-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-02-21

**Type:** ACTUAL

#### Start Date
**Date:** 2022-12-28

**Type:** ACTUAL

**Status Verified Date:** 2023-03

#### Study First Post Date
**Date:** 2023-04-07
**Type:** ACTUAL
**Study First Submit Date:** 2023-03-15
**Study First Submit QC Date:** 2023-03-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hyundai Pharm

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- Alzheimer's disease, Dementia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 24

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 1 tablet contains memantine 20mg/donepezil 10mg

**Intervention Names:**

- Drug: BPDO-1603

**Label:** BPDO-1603

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 1 tablet memantine 20mg and 1 tablet donepezil 10mg

**Intervention Names:**

- Drug: BPDO-1603

**Label:** BPDO-16031,BPDO-16033

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BPDO-1603

- BPDO-16031,BPDO-16033

**Description:** donepezil/mematine

**Name:** BPDO-1603

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** pharmacokinetic properties

**Measure:** Cmax of memantine and donpezil

**Time Frame:** from baseline to day 10

#### Secondary Outcomes

**Description:** pharmacokinetic properties

**Measure:** AUClast of memantine and donpezil

**Time Frame:** from baseline to day 10

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Hyundaipharm

**Zip:** 06121

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M3885

- Name: Alzheimer Disease

- Relevance: LOW

- As Found: Unknown

- ID: T2192

- Name: Familial Alzheimer Disease

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: NootAg

- Name: Nootropic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnDyAg

- Name: Anti-Dyskinesia Agents

### Intervention Browse Module - Browse Leaves

- ID: M1721

- Name: Donepezil

- Relevance: LOW

- As Found: Unknown

- ID: M11542

- Name: Memantine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
