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HealthyPhase 1NCT05481307

A Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interaction and Safety/Tolerability Between RLD2202 and RLD2203

A Phase 1 study testing RLD2202 and RLD2203 in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability between RLD2202 and RLD2203 in healthy adult subjects Read more about this study

Who is it for?
Ages 19 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
RLD2202 and RLD2203
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSouth Korea
Study dates
2 Aug 2022to 25 Oct 2022
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults in the age between 19 and 50 years old
  • Body mass index (BMI) in the range of 18 to 27 kg/m2 and weight 50kg to 90kg.
  • After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
  • Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.

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.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: An Open-label Phase 1 Study to Evaluate PK/PD Drug-drug Interactions and Safety/Tolerability Between RLD2202 and RLD2203 in Healthy Adult Subjects

The purpose of this study is to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability between RLD2202 and RLD2203 in healthy adult subjects

Conditions
Healthy
Being tested
RLD2202, RLD2203

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RLD2202Drug

    Take it once a day per period

  • RLD2203Drug

    Take it once a day per period

Study groups in NCT05481307
Study groupRoleWhat they receive
Fixed SequenceExperimentalPeriod 1: RLD2202, Period 2 : RLD2203 -> RLD2202+RLD2203
Receives: Drug: RLD2202; Drug: RLD2203

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax,ss of RLD2202

    Pharmacokinetic evaluation

    Measured: 0~24 hours

  2. AUCtau,ss of RLD2202

    Pharmacokinetic evaluation

    Measured: 0~24 hours

  3. Cmax,ss of RLD2203

    Pharmacokinetic evaluation

    Measured: 0~24 hours

  4. AUCtau,ss of RLD2203

    Pharmacokinetic evaluation

    Measured: 0~24 hours

  5. Inhibition of Platelet Aggregation(%)

    Pharmacodynamic evaluation

    Measured: 0~6 days

  6. Inhibition of Thromboxane B2(%)

    Pharmacodynamic evaluation

    Measured: 0~6 days

Secondary outcomes (7)

  1. Tmax,ss of RLD2202 and RLD2203

    Pharmacokinetic evaluation

    Measured: 0~24 hours

  2. t1/2,ss of RLD2202 and RLD2203

    Pharmacokinetic evaluation

    Measured: 0~24 hours

  3. Cmin,ss of RLD2202 and RLD2203

    Pharmacokinetic evaluation

    Measured: 0~24 hours

  4. Cavg,ss of RLD2202 and RLD2203

    Pharmacokinetic evaluation

    Measured: 0~24 hours

  5. CLss/F of RLD2202 and RLD2203

    Pharmacokinetic evaluation

    Measured: 0~24 hours

  6. Vdss/F of RLD2202 and RLD2203

    Pharmacokinetic evaluation

    Measured: 0~24 hours

  7. PTF of RLD2202 and RLD2203

    Pharmacokinetic evaluation

    Measured: 0~24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2022
  2. Study start2 Aug 2022
  3. Primary completion25 Oct 2022
  4. Study completion25 Oct 2022

Resources

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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05481307
Sponsor's protocol ID
HM-SARA-101
Status last verified
Sep 2023
First submitted
29 Jul 2022
Last updated
22 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RLD2202 and RLD2203 in people with Healthy, 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?

Cmax,ss of RLD2202 (time frame: 0~24 hours). The study lists 6 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 NCT05481307.

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.

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