HealthyPhase 1NCT03495739
Clinical Trial to Assess the Safety and Pharmacokinetics of RDG-17012 Capsule and Pradaxa® Capsule in Healthy Male Volunteers
A Phase 1 study testing RDG-17012 Capsule and Dabigatran Etexilate Mesylate 150 MG Oral Capsule in people with Healthy, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
A randomized, open-label, single-dosing, 2x2 crossover study, the safety and pharmacokinetics of RDG-17012 with Pradaxa® in healthy male volunteers 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
- Healthy
- What is being tested?
- RDG-17012 Capsule and Dabigatran Etexilate Mesylate 150 MG Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2018to 1 Dec 2018
- 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
- Age between 19 to 45, healthy male subjects(at screening)
- Subject without a hereditary problems, chronic disease and morbid symptom
- Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress
Who cannot join
- Volunteer who has past or present history of any diseases following below.(liver, kidney,digestive system, pulmonary,hematooncology, endocrine, urinary,neurology,mental disorder, skeletomuscular, immunology, otolaryngology,cardiovascular)
- Exceed 2 times the normal range of AST, ALT, Total Bilirubin at screening test
- History of drug abuse, or a positive urine drug screen
- Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
- Any condition that, in the view of the investigator, would interfere with study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of RDG-17012(Dabigatran Etexilate Tosylate) With Pradaxa® Capsule(Dabigatran Etexilate Mesylate) in Healthy Male Volunteers
A randomized, open-label, single-dosing, 2x2 crossover study, the safety and pharmacokinetics of RDG-17012 with Pradaxa® in healthy male volunteers
- Conditions
- Healthy
- Being tested
- RDG-17012 Capsule, Dabigatran Etexilate Mesylate 150 MG Oral Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDG-17012 CapsuleDrug
Dabigatran Etexilate tosylate 150mg
Dabigatran Etexilate Mesylate 150 MG Oral CapsuleDrug
Dabigatran Etexilate mesylate 150mg
| Study group | Role | What they receive |
|---|---|---|
| RDG-17012® capsule | Experimental | RDG-17012 ® capsule(dabigatran etexilate tosylate) Receives: Drug: RDG-17012 Capsule |
| Pradaxa® capsule | Active comparator | Pradaxa® capsule(dabigatran etexilate mesylate) Receives: Drug: Dabigatran Etexilate Mesylate 150 MG Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve(AUC) last of Total dabigatran and Free dabigatran
Measured: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
Maximum of concentration(Cmax) of Total dabigatran and Free dabigatran
Measured: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
Secondary outcomes (1)
Area Under Curve(AUC)inf of Total dabigatran and Free dabigatran
Measured: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Feb 2018
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495739
- Sponsor's protocol ID
- HUG171
- Status last verified
- Apr 2018
- First submitted
- 19 Mar 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of RDG-17012(Dabigatran Etexilate Tosylate) With Pradaxa® Capsule(Dabigatran Etexilate Mesylate) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03495739
- Acronym / sponsor ID
- HUG171
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 12 Apr 2018 (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-dosing, 2x2 crossover study, the safety and pharmacokinetics of RDG-17012 with Pradaxa® in healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RDG-17012® capsule | Experimental | Drug: RDG-17012 CapsuleRDG-17012 ® capsule(dabigatran etexilate tosylate) |
| Pradaxa® capsule | Active comparator | Drug: Dabigatran Etexilate Mesylate 150 MG Oral CapsulePradaxa® capsule(dabigatran etexilate mesylate) |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 19 to 45, healthy male subjects(at screening)
- Subject without a hereditary problems, chronic disease and morbid symptom
- Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress
Key exclusion criteria (5 listed)
- Volunteer who has past or present history of any diseases following below.(liver, kidney,digestive system, pulmonary,hematooncology, endocrine, urinary,neurology,mental disorder, skeletomuscular, immunology, otolaryngology,cardiovascular)
- Exceed 2 times the normal range of AST, ALT, Total Bilirubin at screening test
- History of drug abuse, or a positive urine drug screen
- Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
- Any condition that, in the view of the investigator, would interfere with study participation
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 |
|---|---|---|
| RDG-17012 CapsuleDabigatran Etexilate tosylate 150mg | Drug | RDG-17012® capsule |
| Dabigatran Etexilate Mesylate 150 MG Oral CapsuleDabigatran Etexilate mesylate 150mg | Drug | Pradaxa® capsule |
Primary outcome
Area Under Curve(AUC) last of Total dabigatran and Free dabigatran
Time frame: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
Maximum of concentration(Cmax) of Total dabigatran and Free dabigatran
Time frame: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
1 secondary outcome
Area Under Curve(AUC)inf of Total dabigatran and Free dabigatran
Time frame: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- 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 RDG-17012 Capsule and Dabigatran Etexilate Mesylate 150 MG Oral Capsule in people with Healthy, run by Huons Co., Ltd. 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: status not confirmed, as of the sponsor's last update on 12 Apr 2018. 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?
Results are not available in the source record.
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 Curve(AUC) last of Total dabigatran and Free dabigatran (time frame: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2). 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 12 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.