Healthy VolunteersPhase 1BENCT04905342
NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers
A Phase 1 study testing NVP-1805 and NVP-1805-R1and NVP-1805-R2 in people with Healthy Volunteers, run by NVP Healthcare at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2. 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-1805 and NVP-1805-R1and NVP-1805-R2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Aug 2021to 7 Jan 2022
- 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/㎡ and <30.0 kg/㎡ 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
- Subjects participated in another clinical trial within 6 months prior to administration of the study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Evaluate the Pharmacokinetics and the Safety of NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers
The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.
Read the detailed description
Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2
- Conditions
- Healthy Volunteers
- Being tested
- NVP-1805, NVP-1805-R1and NVP-1805-R2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVP-1805Drug
orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg)
NVP-1805-R1and NVP-1805-R2Drug
orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4) (NVP-1805-R1 80mg, NVP-1805-R2 10/20.8mg)
| Study group | Role | What they receive |
|---|---|---|
| NVP-1805 | Experimental | NVP-1805 (80/10/20.8mg) Receives: Drug: NVP-1805 |
| NVP-1805-R1 and NVP-1805-R2 | Active comparator | coadministration of NVP-1805-R1(80mg) and NVP-1805-R2(10/20.8mg) Receives: Drug: NVP-1805-R1and NVP-1805-R2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of plasma: AUClast
period 1,2,3,4
Measured: 0hours - 72hours
Pharmacokinetics of plasma: Cmax
period 1,2,3,4
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 posted27 May 2021
- Study start14 Aug 2021
- Primary completion20 Dec 2021
- Study completion7 Jan 2022
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
- Model description
- single-dose, crossover study
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- NVP Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaewoo Kim, M.D., Principal investigator, H Plus Yangji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905342
- Sponsor's protocol ID
- NVP-1805_BE-02
- Acronym
- BE
- Status last verified
- Jan 2022
- First submitted
- 24 May 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Evaluate the Pharmacokinetics and the Safety of NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04905342
- Acronym / sponsor ID
- BE / NVP-1805_BE-02
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- NVP HealthcareIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 27 May 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 the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.
Detailed description
Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single-dose, crossover study
| Arm | Type | Receives |
|---|---|---|
| NVP-1805 | Experimental | Drug: NVP-1805NVP-1805 (80/10/20.8mg) |
| NVP-1805-R1 and NVP-1805-R2 | Active comparator | Drug: NVP-1805-R1and NVP-1805-R2coadministration of NVP-1805-R1(80mg) and NVP-1805-R2(10/20.8mg) |
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/㎡ and <30.0 kg/㎡ subject, weight more than 50kg(45 kg or more for woman)
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
- Subjects participated in another clinical trial within 6 months prior to administration of the study drug
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-1805orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg) | Drug | NVP-1805 |
| NVP-1805-R1and NVP-1805-R2orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4) (NVP-1805-R1 80mg, NVP-1805-R2 10/20.8mg) | Drug | NVP-1805-R1 and NVP-1805-R2 |
Primary outcome
Pharmacokinetics of plasma: AUClast
Time frame: 0hours - 72hours
period 1,2,3,4
Pharmacokinetics of plasma: Cmax
Time frame: 0hours - 72hours
period 1,2,3,4
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 Feb 2022.
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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, M.D. 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-1805 and NVP-1805-R1and NVP-1805-R2 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 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 11 Feb 2022. 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: AUClast (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 11 Feb 2022.