HealthyPhase 1NCT03802526
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2
A Phase 1 study testing NVP-1805-R1, NVP-1805-R2 and NVP-1805-R1 and NVP-1805-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/tolerability between NVP-1805-R1 and NVP-1805-R2 Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NVP-1805-R1, NVP-1805-R2 and NVP-1805-R1 and NVP-1805-R2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Apr 2019to 27 Sep 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female adults aged 19-45 years.
- BMI of >18.5 kg/㎡ and <27.0 kg/㎡ subject, weight more than 50kg.
- Voluntarily provided a witten consent to participate in this clinical study.
Who cannot join
- Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
- History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2 in Healthy Volunteers
The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2
Read the detailed description
pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2
- Conditions
- Healthy
- Being tested
- NVP-1805-R1, NVP-1805-R2, NVP-1805-R1 and NVP-1805-R2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVP-1805-R1Drug
Also called NVP-1805-R1(M)
1 tablet, multiple oral dosing
NVP-1805-R2Drug
Also called NVP-1805-R2(C)
1 tablet, multiple oral dosing
NVP-1805-R1 and NVP-1805-R2Drug
Also called NVP-1805-R1(M) and NVP-1805-R2(C)
NVP-1805-R1,1 tablet and NVP-1805-R2, 1 tablet, co-administration, multiple oral dosing
| Study group | Role | What they receive |
|---|---|---|
| NVP-1805-R1 | Experimental | Drug: NVP-1805-R1
1 tablet, oral dosing Receives: Drug: NVP-1805-R1 |
| NVP-1805-R2 | Experimental | Drug: NVP-1805-R2
1 tablet, oral dosing Receives: Drug: NVP-1805-R2 |
| NVP-1805-R1 and NVP-1805-R2 | Experimental | Drug: NVP-1801-R1 1 tablet and NVP-1801-R2 1 tablet co-administration(oral dosing) Receives: Drug: NVP-1805-R1 and NVP-1805-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 - 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start3 Apr 2019
- Primary completion4 Jul 2019
- Study completion27 Sep 2019
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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- NVP Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Sung Shin, M.D., Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802526
- Sponsor's protocol ID
- NVP-1805_DDI
- Status last verified
- Nov 2019
- First submitted
- 10 Jan 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim CH, Kang SI, Shin D. Pharmacokinetic Interaction Between Telmisartan and Rosuvastatin/Ezetimibe After Multiple Oral Administration in Healthy Subjects. Adv Ther. 2021 Feb;38(2):1094-1105. doi: 10.1007/s12325-020-01592-8. Epub 2020 Dec 16.
PubMed 33326064
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03802526
- Acronym / sponsor ID
- NVP-1805_DDI
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- NVP HealthcareIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 14 Jan 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/tolerability between NVP-1805-R1 and NVP-1805-R2
Detailed description
pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NVP-1805-R1 | Experimental | Drug: NVP-1805-R1Drug: NVP-1805-R1 1 tablet, oral dosing |
| NVP-1805-R2 | Experimental | Drug: NVP-1805-R2Drug: NVP-1805-R2 1 tablet, oral dosing |
| NVP-1805-R1 and NVP-1805-R2 | Experimental | Drug: NVP-1805-R1 and NVP-1805-R2Drug: NVP-1801-R1 1 tablet and NVP-1801-R2 1 tablet co-administration(oral dosing) |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female adults aged 19-45 years.
- BMI of >18.5 kg/㎡ and <27.0 kg/㎡ subject, weight more than 50kg.
- Voluntarily provided a witten consent to participate in this clinical study.
Key exclusion criteria (3 listed)
- Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
- History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
- Pregnant or lactating women.
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-1805-R1Also: NVP-1805-R1(M)1 tablet, multiple oral dosing | Drug | NVP-1805-R1 |
| NVP-1805-R2Also: NVP-1805-R2(C)1 tablet, multiple oral dosing | Drug | NVP-1805-R2 |
| NVP-1805-R1 and NVP-1805-R2Also: NVP-1805-R1(M) and NVP-1805-R2(C)NVP-1805-R1,1 tablet and NVP-1805-R2, 1 tablet, co-administration, multiple oral dosing | Drug | NVP-1805-R1 and NVP-1805-R2 |
Primary outcome
Pharmacokinetic interaction
Time frame: 0hours - 48hours
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 29 Nov 2019.
- Derived from this study: PubMed 33326064Kim CH, Kang SI, Shin D. Pharmacokinetic Interaction Between Telmisartan and Rosuvastatin/Ezetimibe After Multiple Oral Administration in Healthy Subjects. Adv Ther. 2021 Feb;38(2):1094-1105. doi: 10.1007/s12325-020-01592-8. Epub 2020 Dec 16.
- 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.
Dong Sung Shin, M.D. principal investigator
Gachon University Gil Medical Center
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-R1, NVP-1805-R2 and NVP-1805-R1 and NVP-1805-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 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 29 Nov 2019. 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 - 48hours). 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 NCT03802526, 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 29 Nov 2019.