HealthyPhase 1NavipharmNCT04181437
Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2
A Phase 1 study testing NVP-1203-R1, NVP-1203-R2 and NVP-1203-R1 and NVP-1203-R2 in people with Healthy, run by NVP Healthcare at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-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
- What is being tested?
- NVP-1203-R1, NVP-1203-R2 and NVP-1203-R1 and NVP-1203-R2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2020to 29 May 2020
- 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
Who cannot join
- Subjects has a history of allergy reaction of study drug ingredient
- 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.
South Korea1 site
Kyungpook National University Hospital
Daegu, Dongdeok-ro, 700-721
About this study
Official title: A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2 in Healthy Adult Subjects
The purpose of this study is to compare the pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2
Read the detailed description
pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2
- Conditions
- Healthy
- Being tested
- NVP-1203-R1, NVP-1203-R2, NVP-1203-R1 and NVP-1203-R2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVP-1203-R1Drug
Also called NVP-1203-R1(A)
1 tablet, Single oral dosing
NVP-1203-R2Drug
Also called NVP-1203-R2(E)
1 tablet, Single oral dosing
NVP-1203-R1 and NVP-1203-R2Drug
Also called NVP-1203-R1(A) and NVP-1203-R2(E)
NVP-1203-R1,1 tablet and NVP-1203-R2, 1 tablet, co-administration, single oral dosing
| Study group | Role | What they receive |
|---|---|---|
| NVP-1203-R1 | Experimental | Drug: NVP-1203-R1
1 tablet, oral dosing Receives: Drug: NVP-1203-R1 |
| NVP-1203-R2 | Experimental | Drug: NVP-1203-R2
1 tablet, oral dosing Receives: Drug: NVP-1203-R2 |
| NVP-1203-R1 and NVP-1203-R2 | Experimental | Drug: NVP-1203-R1 1 tablet and NVP-1203-R2 1 tablet co-administration(oral dosing) Receives: Drug: NVP-1203-R1 and NVP-1203-R2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic interaction
Area under the curve (AUC)
Measured: 0hours - 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start1 May 2020
- Primary completion17 May 2020
- Study completion29 May 2020
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NVP Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoon Y Ran, M.D., Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181437
- Sponsor's protocol ID
- NVP-1203_DDI
- Acronym
- Navipharm
- Status last verified
- Aug 2020
- First submitted
- 26 Nov 2019
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04181437
- Acronym / sponsor ID
- Navipharm / NVP-1203_DDI
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NVP HealthcareIndustry (pharma, biotech, devices)
- Study start
- 1 May 2020 (actual)
- Primary completion
- 17 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 29 Nov 2019 (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 and safety between NVP-1203-R1 and NVP-1203-R2
Detailed description
pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NVP-1203-R1 | Experimental | Drug: NVP-1203-R1Drug: NVP-1203-R1 1 tablet, oral dosing |
| NVP-1203-R2 | Experimental | Drug: NVP-1203-R2Drug: NVP-1203-R2 1 tablet, oral dosing |
| NVP-1203-R1 and NVP-1203-R2 | Experimental | Drug: NVP-1203-R1 and NVP-1203-R2Drug: NVP-1203-R1 1 tablet and NVP-1203-R2 1 tablet co-administration(oral dosing) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adult subjects who signed informed consent
Key exclusion criteria (3 listed)
- Subjects has a history of allergy reaction of study drug ingredient
- 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-1203-R1Also: NVP-1203-R1(A)1 tablet, Single oral dosing | Drug | NVP-1203-R1 |
| NVP-1203-R2Also: NVP-1203-R2(E)1 tablet, Single oral dosing | Drug | NVP-1203-R2 |
| NVP-1203-R1 and NVP-1203-R2Also: NVP-1203-R1(A) and NVP-1203-R2(E)NVP-1203-R1,1 tablet and NVP-1203-R2, 1 tablet, co-administration, single oral dosing | Drug | NVP-1203-R1 and NVP-1203-R2 |
Primary outcome
Pharmacokinetic interaction
Time frame: 0hours - 24hours
Area under the curve (AUC)
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 1 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Yoon Y Ran, M.D. principal investigator
Kyungpook 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-1203-R1, NVP-1203-R2 and NVP-1203-R1 and NVP-1203-R2 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 1 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 1 Sep 2020. 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?
Pharmacokinetic interaction (time frame: 0hours - 24hours). 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 1 Sep 2020.