Healthy VolunteersPhase 1NCT04316065
Bioequivalence Study Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg
A Phase 1 study testing YHP1906 and YHR1902 in people with Healthy Volunteers, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP1906 Tab. 5 mg and YHR1902 Tab. 5mg in healthy 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 Volunteers
- What is being tested?
- YHP1906 and YHR1902
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Apr 2020to 24 Apr 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 adults aged 19 and above with body mass index(BMI) between 18.5 and 30.0 kg/m2
- Acceptable medical history, physical examination and laboratory tests during screening
- Subjects who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detailed explanation of the purpose, contents, and characteristic of the drug
Who cannot join
- History of clinically significant disease
- Administration of ETC(ethical-the-counter drug) within 2 weeks or OTC(over-the-counter drug) within 1 week prior to the first dosing
- Have AST(GOT) and/or ALT(GPT) and/or GGT(γGT) and/or Total Bilirubin > 1.5 times of normal upper limit
- Volunteers considered not eligible for the clinical trial by the investigator
- Administration of other investigational products within 6 months prior to the first dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dose, 2-sequence, 2-period, Crossover Clinical Trial to Investigate the Bioequivalence Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg in Healthy Volunteers
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP1906 Tab. 5 mg and YHR1902 Tab. 5mg in healthy volunteers
Read the detailed description
30 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "comparator" and "YHP1906 Tab. 5 mg" by cross-over design on day 1, 8.
Subjects in group 2 will be administered "YHP1906 Tab. 5 mg" and "comparator" by cross-over design on day 1, 8
- Conditions
- Healthy Volunteers
- Being tested
- YHP1906, YHR1902
- Keywords
- Pharmacokinetics, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHP1906Drug
YHP1906 Tab. 5 mg
YHR1902Drug
Comparator. YHR1902 Tab. 5 mg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | 15 subjects, Cross-over, Single dose of comparator on day 1, Single dose of YHP1906 on day 8 Receives: Drug: YHP1906; Drug: YHR1902 |
| Group 2 | Other | 15 subjects, Cross-over, Single dose of YHP1906 on day 1, Single dose of comparator on day 8 Receives: Drug: YHP1906; Drug: YHR1902 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration-time curve [AUCt]
Area under the plasma drug concentration-time curve [AUCt] of Apixaban
Measured: 0-36 hours
Maximum plasma concentration [Cmax]
Maximum plasma concentration [Cmax] of Apixaban
Measured: 0-36 hours
Secondary outcomes (4)
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Apixaban
Measured: 0-36 hours
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of Apixaban
Measured: 0-36 hours
Time of peak concentration [Tmax]
Time of peak concentration [Tmax] of Apixaban
Measured: 0-36 hours
Terminal phase of half-life [t1/2]
Terminal phase of half-life [t1/2] of Apixaban
Measured: 0-36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start11 Apr 2020
- Primary completion20 Apr 2020
- Study completion24 Apr 2020
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.
- More trials run by Yuhan CorporationThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Metro Hospital
- Responsible party
- Sponsor
- Investigators
- Sungdae Kwon, Principal investigator, Metro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316065
- Sponsor's protocol ID
- YHP1906-101
- Status last verified
- May 2020
- First submitted
- 18 Mar 2020
- Last updated
- 26 May 2020
- 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 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, 2-sequence, 2-period, Crossover Clinical Trial to Investigate the Bioequivalence Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04316065
- Acronym / sponsor ID
- YHP1906-101
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Metro Hospital
- Study start
- 11 Apr 2020 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 20 Mar 2020 (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.
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP1906 Tab. 5 mg and YHR1902 Tab. 5mg in healthy volunteers
Detailed description
30 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "comparator" and "YHP1906 Tab. 5 mg" by cross-over design on day 1, 8.
Subjects in group 2 will be administered "YHP1906 Tab. 5 mg" and "comparator" by cross-over design on day 1, 8
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: YHP1906, Drug: YHR190215 subjects, Cross-over, Single dose of comparator on day 1, Single dose of YHP1906 on day 8 |
| Group 2 | Other | Drug: YHP1906, Drug: YHR190215 subjects, Cross-over, Single dose of YHP1906 on day 1, Single dose of comparator on day 8 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults aged 19 and above with body mass index(BMI) between 18.5 and 30.0 kg/m2
- Acceptable medical history, physical examination and laboratory tests during screening
- Subjects who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detailed explanation of the purpose, contents, and characteristic of the drug
Key exclusion criteria (5 listed)
- History of clinically significant disease
- Administration of ETC(ethical-the-counter drug) within 2 weeks or OTC(over-the-counter drug) within 1 week prior to the first dosing
- Have AST(GOT) and/or ALT(GPT) and/or GGT(γGT) and/or Total Bilirubin > 1.5 times of normal upper limit
- Volunteers considered not eligible for the clinical trial by the investigator
- Administration of other investigational products within 6 months prior to the first dosing
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 |
|---|---|---|
| YHP1906YHP1906 Tab. 5 mg | Drug | Group 1, Group 2 |
| YHR1902Comparator. YHR1902 Tab. 5 mg | Drug | Group 1, Group 2 |
Primary outcome
Area under the plasma drug concentration-time curve [AUCt]
Time frame: 0-36 hours
Area under the plasma drug concentration-time curve [AUCt] of Apixaban
Maximum plasma concentration [Cmax]
Time frame: 0-36 hours
Maximum plasma concentration [Cmax] of Apixaban
4 secondary outcomes
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
Time frame: 0-36 hours
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
Time frame: 0-36 hours
Time of peak concentration [Tmax]
Time frame: 0-36 hours
Terminal phase of half-life [t1/2]
Time frame: 0-36 hours
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 26 May 2020.
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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.
Sungdae Kwon principal investigator
Metro 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 YHP1906 and YHR1902 in people with Healthy Volunteers, run by Yuhan Corporation 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 5 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 26 May 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?
Area under the plasma drug concentration-time curve [AUCt] (time frame: 0-36 hours). 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 26 May 2020.