Rheumatoid ArthritisNCT01688193
Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male
An observational study of Rheumatoid Arthritis, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Dec 2012
- Phase
- Observational
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: healthy korean male
Who may be able to join
- BMI: 18.0 - 27.0 kg/m2
- Willingness to sign the written Informed Consent Form
Who cannot join
- Evidence of clinically relevant pathology
- History of relevant drug and food allergies
- Positive screen on drugs of abuse
- Participation in a drug study within 60 days prior to drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open, 2-way Cross Over, Single Dose Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male
The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCP 1004 | Not described | |
| Vimovo 500/20mg | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast, Cmax of Naproxen and Esomeprazole
Measured: Naproxen : 0h,30min, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72h, Esomeprazole : 0h, 10min, 20min, 30min, 45min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12h
Secondary outcomes (1)
Tmax, t1/2, CL/F, AUCinf of Naproxen and Esomeprazole
Measured: Naproxen : 0h, 30min, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72h Esomeprazole: 0h, 10min, 20min, 30min, 45min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
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 Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688193
- Sponsor's protocol ID
- HM-ESNP-102
- Status last verified
- Jan 2013
- First submitted
- 14 Sep 2012
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang-Smith L, Fort J, Zhang Y, Sostek M. Pharmacokinetics and relative bioavailability of a fixed-dose combination of enteric-coated naproxen and non-enteric-coated esomeprazole magnesium. J Clin Pharmacol. 2012 May;52(5):670-80. doi: 10.1177/0091270011405500. Epub 2011 May 31.
PubMed 21628602
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open, 2-way Cross Over, Single Dose Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male
- ClinicalTrials.gov ID
- NCT01688193
- Acronym / sponsor ID
- HM-ESNP-102
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Sep 2012 (estimated)
- 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 and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCP 1004 | – | – |
| Vimovo 500/20mg | – | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy korean male
Key inclusion criteria (2 listed)
- BMI: 18.0 - 27.0 kg/m2
- Willingness to sign the written Informed Consent Form
Key exclusion criteria (4 listed)
- Evidence of clinically relevant pathology
- History of relevant drug and food allergies
- Positive screen on drugs of abuse
- Participation in a drug study within 60 days prior to drug administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AUClast, Cmax of Naproxen and Esomeprazole
Time frame: Naproxen : 0h,30min, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72h, Esomeprazole : 0h, 10min, 20min, 30min, 45min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12h
1 secondary outcome
Tmax, t1/2, CL/F, AUCinf of Naproxen and Esomeprazole
Time frame: Naproxen : 0h, 30min, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72h Esomeprazole: 0h, 10min, 20min, 30min, 45min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12h
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 7 Jan 2013.
- Background: PubMed 21628602Wang-Smith L, Fort J, Zhang Y, Sostek M. Pharmacokinetics and relative bioavailability of a fixed-dose combination of enteric-coated naproxen and non-enteric-coated esomeprazole magnesium. J Clin Pharmacol. 2012 May;52(5):670-80. doi: 10.1177/0091270011405500. Epub 2011 May 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hanmi Pharmaceutical Company Limited 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 4 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 7 Jan 2013. 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.
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?
AUClast, Cmax of Naproxen and Esomeprazole (time frame: Naproxen : 0h,30min, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72h, Esomeprazole : 0h, 10min, 20min, 30min, 45min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12h). 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 NCT01688193, 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 7 Jan 2013.