Healthy VolunteersPhase 1NCT05862090
A Study to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 in Healthy Volunteers
A Phase 1 study testing RLD2301 and RLD2007 in people with Healthy Volunteers, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the drug-drug interaction and safety of RLD2301 and RLD2007 after oral administration in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- RLD2301 and RLD2007
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2023to 26 May 2023
- 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 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 19~54 years in healthy volunteers
- 18.5 kg/m^2 ≤ BMI < 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
- 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <90 mmHg
- Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial
Who cannot join
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Subjects who judged ineligible by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Multiple Dose, Crossover Clinical Trial to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 After Oral Administration in Healthy Volunteers
The purpose of this study is to evaluate the drug-drug interaction and safety of RLD2301 and RLD2007 after oral administration in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- RLD2301, RLD2007
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLD2301Drug
Take it once a day per period.
RLD2007Drug
Take it once a day per period.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (First RLD2301, then RLD2301+RLD2007) | Experimental | Period1 : RLD2301 Period2 : RLD2301 + RLD2007 Receives: Drug: RLD2301; Drug: RLD2007 |
| Arm 2 (First RLD2007, then RLD2301+RLD2007) | Experimental | Period1 : RLD2007 Period2 : RLD2301 + RLD2007 Receives: Drug: RLD2301; Drug: RLD2007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau
Pharmacokinetic evaluation
Measured: 0~24 hours after final dose administration
Css,max
Pharmacokinetic evaluation
Measured: 0~24 hours after final dose administration
Secondary outcomes (8)
Css,min
Pharmacokinetic evaluation
Measured: 0~24 hours after final dose administration
Css,av
Pharmacokinetic evaluation
Measured: 0~24 hours after final dose administration
Tss,max
Pharmacokinetic evaluation
Measured: 0~24 hours after final dose administration
t1/2
Pharmacokinetic evaluation
Measured: 0~24 hours after final dose administration
CLss/F
Pharmacokinetic evaluation
Measured: 0~24 hours after final dose administration
Vdss/F
Pharmacokinetic evaluation
Measured: 0~24 hours after final dose administration
Fluctuation[(Css,max-Css,min)/Css,av]
Pharmacokinetic evaluation
Measured: 0~24 hours after final dose administration
Swing[(Css,max-Css,min)/Css,min]
Pharmacokinetic evaluation
Measured: 0~24 hours after final dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start5 Apr 2023
- Primary completion26 May 2023
- Study completion26 May 2023
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 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-gul Kim, MD, Principal investigator, Jeonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862090
- Sponsor's protocol ID
- HM-ENSEMBLE-101
- Status last verified
- Sep 2023
- First submitted
- 8 May 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multiple Dose, Crossover Clinical Trial to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 After Oral Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05862090
- Acronym / sponsor ID
- HM-ENSEMBLE-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 17 May 2023 (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 purpose of this study is to evaluate the drug-drug interaction and safety of RLD2301 and RLD2007 after oral administration in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (First RLD2301, then RLD2301+RLD2007) | Experimental | Drug: RLD2301, Drug: RLD2007Period1 : RLD2301 Period2 : RLD2301 + RLD2007 |
| Arm 2 (First RLD2007, then RLD2301+RLD2007) | Experimental | Drug: RLD2301, Drug: RLD2007Period1 : RLD2007 Period2 : RLD2301 + RLD2007 |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 19~54 years in healthy volunteers
- 18.5 kg/m^2 ≤ BMI < 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
- 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <90 mmHg
- Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial
Key exclusion criteria (2 listed)
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Subjects who judged ineligible by the investigator
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 |
|---|---|---|
| RLD2301Take it once a day per period. | Drug | Arm 1 (First RLD2301, then RLD2301+RLD2007), Arm 2 (First RLD2007, then RLD2301+RLD2007) |
| RLD2007Take it once a day per period. | Drug | Arm 1 (First RLD2301, then RLD2301+RLD2007), Arm 2 (First RLD2007, then RLD2301+RLD2007) |
Primary outcome
AUCtau
Time frame: 0~24 hours after final dose administration
Pharmacokinetic evaluation
Css,max
Time frame: 0~24 hours after final dose administration
Pharmacokinetic evaluation
8 secondary outcomes
Css,min
Time frame: 0~24 hours after final dose administration
Css,av
Time frame: 0~24 hours after final dose administration
Tss,max
Time frame: 0~24 hours after final dose administration
t1/2
Time frame: 0~24 hours after final dose administration
CLss/F
Time frame: 0~24 hours after final dose administration
Vdss/F
Time frame: 0~24 hours after final dose administration
Fluctuation[(Css,max-Css,min)/Css,av]
Time frame: 0~24 hours after final dose administration
Swing[(Css,max-Css,min)/Css,min]
Time frame: 0~24 hours after final dose administration
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 22 Sep 2023.
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Screening Protocol
Pain
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.
Min-gul Kim, MD principal investigator
Jeonbuk National University 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 RLD2301 and RLD2007 in people with Healthy Volunteers, 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 4 inclusion and 2 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 22 Sep 2023. 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?
AUCtau (time frame: 0~24 hours after final dose administration). 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 22 Sep 2023.