Healthy VolunteerPhase 1NCT05418803
BE Study of Two Formulations of Rivaroxaban 2.5 mg in Healthy Subjects
A Phase 1 study testing YHP1807 Tab. 2.5mg and YHR1901 Tab. 2.5mg in people with Healthy Volunteer, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The objective of this study was to compare the pharmacokinetic profiles and bioequivalence of rivaroxaban after a single oral dose of rivaroxaban 2.5 mg tablet in healthy Korean subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- YHP1807 Tab. 2.5mg and YHR1901 Tab. 2.5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jan 2020to 14 Feb 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
- Acceptable medical history, physical examination, laboratory tests and EKG, during screening
- Subjects who has signed a written informed consent voluntarily
Who cannot join
- History of clinically significant medical history or current disease
- Hypotension (SBP ≤ 90 mmHg or DBP ≤ 60 mmHg) or hypertension (SBP
- ≥ 140 mmHg or DBP ≥ 90 mmHg).
- AST(SGOT) or/and ALT(SGPT) > 1.5 times of normal upper limit
- Total bilirubin > 2.0 mg/dl
- Volunteers considered not eligible for the clinical trial by the investigator
- Administration of other investigational products within 6 month prior to the first dosing.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
About this study
Official title: An Open-label, Randomized, 2-sequence, 2-period, Fasted, Single Dose, Oral Administration, Crossover Study to Evaluate the Bioequivalence of YHP1807 Tablets 2.5 mg and YHR1901 Tablets 2.5 mg in Healthy Volunteers
The objective of this study was to compare the pharmacokinetic profiles and bioequivalence of rivaroxaban after a single oral dose of rivaroxaban 2.5 mg tablet in healthy Korean subjects.
Read the detailed description
This study was a randomized, open-label, single-dose, two-period, crossover study which included 34 healthy adult male and female subjects under fasting conditions. A single dose of experimental drug or comparator was administered in each of the two study periods (separated by a washout period of 1 week). Serial blood samples were collected up to 36 hours post-dose. Plasma drug concentrations were measured by liquid chromatography/tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters, including maximum plasma concentration (Cmax) and area under the plasma concentration versus time curve from dosing to the last measurable concentration (AUCt), were determined by non-compartmental analysis. The geometric mean ratios and associated 90% confidence intervals (CIs) of log-transformed Cmax and AUCt were calculated to evaluate pharmacokinetic equivalence.
- Conditions
- Healthy Volunteer
- Being tested
- YHP1807 Tab. 2.5mg, YHR1901 Tab. 2.5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHP1807 Tab. 2.5mgDrug
Also called Experimental
Rivaroxaban 2.5mg
YHR1901 Tab. 2.5mgDrug
Also called Active comparator
Rivaroxaban 2.5mg
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | 17 subjects, Cross-over, Single dose of comparator on day1, YHP1807 on day8 Receives: Drug: YHP1807 Tab. 2.5mg; Drug: YHR1901 Tab. 2.5mg |
| Group2 | Active comparator | 17 subjects, Cross-over, Single dose of YHP1807 on day1, comparator on day8 Receives: Drug: YHP1807 Tab. 2.5mg; Drug: YHR1901 Tab. 2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
AUCt of Rivaroxaban
Measured: 0-36 hours
Cmax
Cmax of Rivaroxaban
Measured: 0-36 hours
Secondary outcomes (3)
AUCinf
AUCinf of Rivaroxaban
Measured: 0-36 hours
Tmax
Tmax of Rivaroxaban
Measured: 0-36 hours
t1/2
t1/2 of Rivaroxaban
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 posted14 Jun 2022
- Study start28 Jan 2020
- Primary completion14 Feb 2020
- Study completion14 Feb 2020
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 Healthy VolunteerStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418803
- Sponsor's protocol ID
- YHP1807-101
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to ejsong@yuhan.co.kr. A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov).
Publications
Moon SJ, Kim Y, Kim SY, Jeon JY, Song E, Lim Y, Kim MG. Comparative pharmacokinetics of two formulations of 2.5-mg rivaroxaban in healthy Korean subjects. Int J Clin Pharmacol Ther. 2023 Mar 5. doi: 10.5414/CP204335. Online ahead of print.
PubMed 36871246
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, 2-sequence, 2-period, Fasted, Single Dose, Oral Administration, Crossover Study to Evaluate the Bioequivalence of YHP1807 Tablets 2.5 mg and YHR1901 Tablets 2.5 mg in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05418803
- Acronym / sponsor ID
- YHP1807-101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 14 Jun 2022 (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 objective of this study was to compare the pharmacokinetic profiles and bioequivalence of rivaroxaban after a single oral dose of rivaroxaban 2.5 mg tablet in healthy Korean subjects.
Detailed description
This study was a randomized, open-label, single-dose, two-period, crossover study which included 34 healthy adult male and female subjects under fasting conditions. A single dose of experimental drug or comparator was administered in each of the two study periods (separated by a washout period of 1 week). Serial blood samples were collected up to 36 hours post-dose. Plasma drug concentrations were measured by liquid chromatography/tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters, including maximum plasma concentration (Cmax) and area under the plasma concentration versus time curve from dosing to the last measurable concentration (AUCt), were determined by non-compartmental analysis. The geometric mean ratios and associated 90% confidence intervals (CIs) of log-transformed Cmax and AUCt were calculated to evaluate pharmacokinetic equivalence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Drug: YHP1807 Tab. 2.5mg, Drug: YHR1901 Tab. 2.5mg17 subjects, Cross-over, Single dose of comparator on day1, YHP1807 on day8 |
| Group2 | Active comparator | Drug: YHP1807 Tab. 2.5mg, Drug: YHR1901 Tab. 2.5mg17 subjects, Cross-over, Single dose of YHP1807 on day1, comparator on day8 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
- Acceptable medical history, physical examination, laboratory tests and EKG, during screening
- Subjects who has signed a written informed consent voluntarily
Key exclusion criteria (7 listed)
- History of clinically significant medical history or current disease
- Hypotension (SBP ≤ 90 mmHg or DBP ≤ 60 mmHg) or hypertension (SBP
- ≥ 140 mmHg or DBP ≥ 90 mmHg).
- AST(SGOT) or/and ALT(SGPT) > 1.5 times of normal upper limit
- Total bilirubin > 2.0 mg/dl
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 |
|---|---|---|
| YHP1807 Tab. 2.5mgAlso: ExperimentalRivaroxaban 2.5mg | Drug | Group1, Group2 |
| YHR1901 Tab. 2.5mgAlso: Active comparatorRivaroxaban 2.5mg | Drug | Group1, Group2 |
Primary outcome
AUCt
Time frame: 0-36 hours
AUCt of Rivaroxaban
Cmax
Time frame: 0-36 hours
Cmax of Rivaroxaban
3 secondary outcomes
AUCinf
Time frame: 0-36 hours
Tmax
Time frame: 0-36 hours
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 16 Jun 2022.
- Derived from this study: PubMed 36871246Moon SJ, Kim Y, Kim SY, Jeon JY, Song E, Lim Y, Kim MG. Comparative pharmacokinetics of two formulations of 2.5-mg rivaroxaban in healthy Korean subjects. Int J Clin Pharmacol Ther. 2023 Mar 5. doi: 10.5414/CP204335. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to ejsong@yuhan.co.kr. A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov).
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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?
A Phase 1 study testing YHP1807 Tab. 2.5mg and YHR1901 Tab. 2.5mg in people with Healthy Volunteer, 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 7 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 16 Jun 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?
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?
On the ClinicalTrials.gov record for NCT05418803, 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 16 Jun 2022.