HealthyPhase 1NCT04961905
Pharmacokinetic Characteristics and Safety After Administration of NVP-2002
A Phase 1 study testing NVP-2002-R1+NVP-2002-R2 and NVP-2002 in people with Healthy, run by NVP Healthcare at 1 site in South Korea.
Trial summary
The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2 in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NVP-2002-R1+NVP-2002-R2 and NVP-2002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Sep 2022to 30 May 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
- Body Mass Index(BMI)=18.5~29.9kg/㎡
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
- Upper Limits of Normal x 1.5 < Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jeonbuk national university hospital
Jeonju, Jeollabuk-do, 54907
About this study
Official title: A Phase I Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and Safety After Administration of NVP-2002 and Co-administration of NVP-2002-R1 and NVP-2002-R2 in Healthy Adult Volunteers
The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2 in healthy adult volunteers.
Read the detailed description
Phase 1 to evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2. Which is designed as ramdomized, oral, single dose, 2×2 crossover.
- Conditions
- Healthy
- Being tested
- NVP-2002-R1+NVP-2002-R2, NVP-2002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVP-2002-R1+NVP-2002-R2Drug
NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily
NVP-2002Drug
NVP-2002 is a combination of NVP-2002-R1 and NVP-2002_R2 NVP-2002, 1 tablet, once daily
| Study group | Role | What they receive |
|---|---|---|
| Single tablet fist, fasted | Experimental | single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition Receives: Drug: NVP-2002-R1+NVP-2002-R2 |
| FDC fist, fasted | Experimental | NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition Receives: Drug: NVP-2002 |
| Single tablet fist, fed | Experimental | single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition Receives: Drug: NVP-2002-R1+NVP-2002-R2 |
| FDC fist, fed | Experimental | NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition Receives: Drug: NVP-2002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of plasma: Cmax
Cmax of NVP-2002-R1 and NVP-2002-R2
Measured: 0hours - 72hours
Pharmacokinetics of plasma: AUCt
Area under the curve of NVP-2002-R1 and NVP-2002-R2
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 posted14 Jul 2021
- Study start3 Sep 2022
- Primary completion25 Apr 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- NVP Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Gul Kim, M.D., Ph.D, Principal investigator, Jeonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961905
- Sponsor's protocol ID
- NVP-2002_BA
- Status last verified
- Oct 2023
- First submitted
- 29 Jun 2021
- Last updated
- 5 Oct 2023
- 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 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and Safety After Administration of NVP-2002 and Co-administration of NVP-2002-R1 and NVP-2002-R2 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04961905
- Acronym / sponsor ID
- NVP-2002_BA
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- NVP HealthcareIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 14 Jul 2021 (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 compare and evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2 in healthy adult volunteers.
Detailed description
Phase 1 to evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2. Which is designed as ramdomized, oral, single dose, 2×2 crossover.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single tablet fist, fasted | Experimental | Drug: NVP-2002-R1+NVP-2002-R2single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition |
| FDC fist, fasted | Experimental | Drug: NVP-2002NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition |
| Single tablet fist, fed | Experimental | Drug: NVP-2002-R1+NVP-2002-R2single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition |
| FDC fist, fed | Experimental | Drug: NVP-2002NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition |
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
- Body Mass Index(BMI)=18.5~29.9kg/㎡
Key exclusion criteria (3 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
- Upper Limits of Normal x 1.5 < Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin
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-2002-R1+NVP-2002-R2NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily | Drug | Single tablet fist, fasted, Single tablet fist, fed |
| NVP-2002NVP-2002 is a combination of NVP-2002-R1 and NVP-2002_R2 NVP-2002, 1 tablet, once daily | Drug | FDC fist, fasted, FDC fist, fed |
Primary outcome
Pharmacokinetics of plasma: Cmax
Time frame: 0hours - 72hours
Cmax of NVP-2002-R1 and NVP-2002-R2
Pharmacokinetics of plasma: AUCt
Time frame: 0hours - 72hours
Area under the curve of NVP-2002-R1 and NVP-2002-R2
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 5 Oct 2023.
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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.
Min-Gul Kim, M.D., Ph.D principal investigator
Jeonbuk National University 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-2002-R1+NVP-2002-R2 and NVP-2002 in people with Healthy, 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 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 5 Oct 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?
Pharmacokinetics of plasma: Cmax (time frame: 0hours - 72hours). The study lists 2 primary outcomes in all. 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 5 Oct 2023.