HealthyPhase 1NCT05804279
Pharmacokinetics of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults
A Phase 1 study testing BPDO-1603 in people with Healthy, run by Hyundai Pharm at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BPDO-1603
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Dec 2022to 14 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Healthy
- Being tested
- BPDO-1603
- Keywords
- Alzheimer's disease, Dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPDO-1603Drug
donepezil/mematine
| Study group | Role | What they receive |
|---|---|---|
| BPDO-1603 | Experimental | 1 tablet contains memantine 20mg/donepezil 10mg Receives: Drug: BPDO-1603 |
| BPDO-16031,BPDO-16033 | Active comparator | 1 tablet memantine 20mg and 1 tablet donepezil 10mg Receives: Drug: BPDO-1603 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of memantine and donpezil
pharmacokinetic properties
Measured: from baseline to day 10
Secondary outcomes (1)
AUClast of memantine and donpezil
pharmacokinetic properties
Measured: from baseline to day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start28 Dec 2022
- Primary completion21 Feb 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyundai Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804279
- Sponsor's protocol ID
- HT-007-05
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choi M, Jin BH, Keum DH, Mo KH, Park MS, Lee J, Park S, Kim CO. Bioequivalence of a Donepezil/Memantine 10/20 mg Fixed-Dose Combination Versus Single-Component Tablets in Healthy Korean Males. Clin Pharmacol Drug Dev. 2025 Sep;14(9):710-716. doi: 10.1002/cpdd.1556. Epub 2025 May 30.
PubMed 40444644
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05804279
- Acronym / sponsor ID
- HT-007-05
- Conditions
- Healthy
- Keywords
- Alzheimer's disease, Dementia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hyundai PharmIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPDO-1603 | Experimental | Drug: BPDO-16031 tablet contains memantine 20mg/donepezil 10mg |
| BPDO-16031,BPDO-16033 | Active comparator | Drug: BPDO-16031 tablet memantine 20mg and 1 tablet donepezil 10mg |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPDO-1603donepezil/mematine | Drug | BPDO-1603, BPDO-16031,BPDO-16033 |
Primary outcome
Cmax of memantine and donpezil
Time frame: from baseline to day 10
pharmacokinetic properties
1 secondary outcome
AUClast of memantine and donpezil
Time frame: from baseline to day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Derived from this study: PubMed 40444644Choi M, Jin BH, Keum DH, Mo KH, Park MS, Lee J, Park S, Kim CO. Bioequivalence of a Donepezil/Memantine 10/20 mg Fixed-Dose Combination Versus Single-Component Tablets in Healthy Korean Males. Clin Pharmacol Drug Dev. 2025 Sep;14(9):710-716. doi: 10.1002/cpdd.1556. Epub 2025 May 30.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BPDO-1603 in people with Healthy, run by Hyundai Pharm at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of memantine and donpezil (time frame: from baseline to day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05804279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.