Healthy VolunteersPhase 1NCT05725252
To Evaluate the Safety and the Pharmacokinetics of NVP-2203
A Phase 1 study testing NVP-2203 and NVP-2203-R in people with Healthy Volunteers, run by NVP Healthcare at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and pharmacokinetics after administration of NVP-2203. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- NVP-2203 and NVP-2203-R
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 May 2023to 5 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult subjects who signed informed consent
- BMI of >18.0 kg/m2 and <30.0 kg/m2 subject, weight more than 50kg(45 kg or more for woman)
Who cannot join
- Subjects participated in another clinical trial within 6 months prior to administration of the study drug
- Inadequate subject for the clinical trial by the investigator's decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of NVP-2203 in Healthy Adult Volunteers
The purpose of this study is to evaluate the safety and pharmacokinetics after administration of NVP-2203.
Read the detailed description
Phase 1 to evaluate the safety and pharmacokinetics after administration of NVP-2203.
- Conditions
- Healthy Volunteers
- Being tested
- NVP-2203, NVP-2203-R
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVP-2203Drug
NVP-2203(Combination of NVP-2203-R1 and NVP-2203-R2)
NVP-2203-RDrug
administration of active comparator
| Study group | Role | What they receive |
|---|---|---|
| NVP-2203 | Experimental | After fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2) Receives: Drug: NVP-2203 |
| NVP-2203-R | Active comparator | After fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2) Receives: Drug: NVP-2203-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
NVP-2203's pharmacokinetics of plasma
AUCt
Measured: 0hours - 72hours
Secondary outcomes (1)
pharmacokinetics of plasma
Cmax
Measured: 0hours - 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start28 May 2023
- Primary completion11 Jun 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NVP Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaewoo Kim, Principal investigator, H Plus Yangji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725252
- Sponsor's protocol ID
- NVP-2203_BA
- Status last verified
- Oct 2023
- First submitted
- 24 Jan 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of NVP-2203 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05725252
- Acronym / sponsor ID
- NVP-2203_BA
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NVP HealthcareIndustry (pharma, biotech, devices)
- Study start
- 28 May 2023 (actual)
- Primary completion
- 11 Jun 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 13 Feb 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.
The purpose of this study is to evaluate the safety and pharmacokinetics after administration of NVP-2203.
Detailed description
Phase 1 to evaluate the safety and pharmacokinetics after administration of NVP-2203.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVP-2203 | Experimental | Drug: NVP-2203After fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2) |
| NVP-2203-R | Active comparator | Drug: NVP-2203-RAfter fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adult subjects who signed informed consent
- BMI of >18.0 kg/m2 and <30.0 kg/m2 subject, weight more than 50kg(45 kg or more for woman)
Key exclusion criteria (2 listed)
- Subjects participated in another clinical trial within 6 months prior to administration of the study drug
- Inadequate subject for the clinical trial by the investigator's decision
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 |
|---|---|---|
| NVP-2203NVP-2203(Combination of NVP-2203-R1 and NVP-2203-R2) | Drug | NVP-2203 |
| NVP-2203-Radministration of active comparator | Drug | NVP-2203-R |
Primary outcome
NVP-2203's pharmacokinetics of plasma
Time frame: 0hours - 72hours
AUCt
1 secondary outcome
pharmacokinetics of plasma
Time frame: 0hours - 72hours
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 11 Jan 2024.
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Screening Protocol
Pain
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.
Jaewoo Kim principal investigator
H Plus Yangji Hospital
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 NVP-2203 and NVP-2203-R in people with Healthy Volunteers, run by NVP Healthcare 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 2 inclusion and 2 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 11 Jan 2024. 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?
NVP-2203's pharmacokinetics of plasma (time frame: 0hours - 72hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2024.