Embolism and ThrombosisPhase 1NCT05128591
A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091
A Phase 1 study testing Rivaroxaban 18mg Oral Tablet and Rivaroxaban 20 MG Oral Tablet in people with Embolism and Thrombosis, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-109 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Embolism and Thrombosis
- What is being tested?
- Rivaroxaban 18mg Oral Tablet and Rivaroxaban 20 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Nov 2021to 31 Dec 2021
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 in healthy male volunteers at the time of screening visit
Who cannot join
- Patients with Medical history increasing the risk of bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study Under Fed State to Evaluate the Safety and Pharmacokinetics of AD-109 in Healthy Male Volunteers
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-109 in healthy male subjects.
Read the detailed description
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-109 compared with AD-1091 in healthy male subjects.
- Conditions
- Embolism and Thrombosis
- Being tested
- Rivaroxaban 18mg Oral Tablet, Rivaroxaban 20 MG Oral Tablet
- Medical subject headings
- Embolism and Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 18mg Oral TabletDrug
AD-109 (Rivaroxaban 18mg) Oral Tablet
Rivaroxaban 20 MG Oral TabletDrug
AD-1091 (Rivaroxaban 20mg) Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm A-Rivaroxaban | Experimental | Period 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109) Receives: Drug: Rivaroxaban 18mg Oral Tablet; Drug: Rivaroxaban 20 MG Oral Tablet |
| Arm B-Rivaroxaban | Experimental | Period 1 : Test Drug(AD-109) Period 2 : Reference Drug(AD-1091 Receives: Drug: Rivaroxaban 18mg Oral Tablet; Drug: Rivaroxaban 20 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Cmax of Rivaroxaban
Measured: pre-dose to 34 hours
Area Under the Curve in time plot (AUCt)
AUCt of Rivaroxaban
Measured: pre-dose to 34 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start9 Nov 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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 Embolism and ThrombosisStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.The 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128591
- Sponsor's protocol ID
- AD-109BE
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryu H, Cho JY, Lee T, Kim J, Lee S. Assessment of Pharmacokinetics and Food Effect of AD-109, a Novel Formulation of Rivaroxaban 18 mg. Clin Transl Sci. 2025 Dec;18(12):e70439. doi: 10.1111/cts.70439.
PubMed 41332264
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study Under Fed State to Evaluate the Safety and Pharmacokinetics of AD-109 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT05128591
- Acronym / sponsor ID
- AD-109BE
- Conditions
- Embolism and Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Nov 2021 (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.
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-109 in healthy male subjects.
Detailed description
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-109 compared with AD-1091 in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A-Rivaroxaban | Experimental | Drug: Rivaroxaban 18mg Oral Tablet, Drug: Rivaroxaban 20 MG Oral TabletPeriod 1 : Reference Drug(AD-1091) Period 2 : Test Drug(AD-109) |
| Arm B-Rivaroxaban | Experimental | Drug: Rivaroxaban 18mg Oral Tablet, Drug: Rivaroxaban 20 MG Oral TabletPeriod 1 : Test Drug(AD-109) Period 2 : Reference Drug(AD-1091 |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 in healthy male volunteers at the time of screening visit
Key exclusion criteria (1 listed)
- Patients with Medical history increasing the risk of bleeding
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 |
|---|---|---|
| Rivaroxaban 18mg Oral TabletAD-109 (Rivaroxaban 18mg) Oral Tablet | Drug | Arm A-Rivaroxaban, Arm B-Rivaroxaban |
| Rivaroxaban 20 MG Oral TabletAD-1091 (Rivaroxaban 20mg) Oral Tablet | Drug | Arm A-Rivaroxaban, Arm B-Rivaroxaban |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: pre-dose to 34 hours
Cmax of Rivaroxaban
Area Under the Curve in time plot (AUCt)
Time frame: pre-dose to 34 hours
AUCt of Rivaroxaban
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 8 Mar 2022.
- Derived from this study: PubMed 41332264Ryu H, Cho JY, Lee T, Kim J, Lee S. Assessment of Pharmacokinetics and Food Effect of AD-109, a Novel Formulation of Rivaroxaban 18 mg. Clin Transl Sci. 2025 Dec;18(12):e70439. doi: 10.1111/cts.70439.
- 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.
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 Rivaroxaban 18mg Oral Tablet and Rivaroxaban 20 MG Oral Tablet in people with Embolism and Thrombosis, run by Addpharma Inc. 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 1 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 8 Mar 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?
Peak Plasma Concentration (Cmax) (time frame: pre-dose to 34 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 NCT05128591, 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 8 Mar 2022; AzTrials last refreshed its copy on 2 Nov 2026.