HealthyPhase 1NCT03826485
Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects
A Phase 1 study testing PRIC and Pranlukast hydrate in people with Healthy, run by SamA Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is Safety, Pharmacokinetic Study of PRIC Read more about this study
- Who is it for?
- Ages 19 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PRIC and Pranlukast hydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2019to 31 Jul 2019
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19 to 45 years old healthy male subject at the screening
- Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study
Who cannot join
- Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- Subjects with history of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, ear, nose and throat (ENT), respiratory, musculoskeletal, infectious, gastrointestinal, liver, biliary, endocrine, renal, genitourinary, nervous, psychiatric, blood disorders, tumors, fractures or any other conditions
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center
Seoul, Songpa-gu
Hyung Suk Lim, MD, Ph.D.
About this study
Official title: A Randomized, Open-label, Single-dose, Crossover Study to Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup in Healthy Male Volunteers
The purpose of this study is Safety, Pharmacokinetic Study of PRIC
Read the detailed description
- To Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup
- To evaluate the safety and tolerability of PRIC and Pranlukast Dry Syrup
- Conditions
- Healthy
- Being tested
- PRIC, Pranlukast hydrate
- Keywords
- Pranlukast hydrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRICDrug
Also called PRIC 50mg
Pranlukast hydrate 50mg
Pranlukast hydrateDrug
Pranlukast hydrate 225mg/2.25g
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | Period 1: PRIC Period 2: Pranlukast hydrate Receives: Drug: PRIC; Drug: Pranlukast hydrate |
| B group | Experimental | Period 1: Pranlukast hydrate Period 2: PRIC Receives: Drug: PRIC; Drug: Pranlukast hydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) to last time point (t)
Area under the PRIC/Pranlukast dry syrup concentration in blood-time curve from zero to the final
Measured: 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose
Maximum concentration of drug (Cmax)
The maximum PRIC/Pranlukast dry syrup concentration in blood sampling time t
Measured: 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Apr 2019 (estimated)
- Primary completion25 Apr 2019 (estimated)
- Study completion31 Jul 2019 (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
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SamA Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826485
- Sponsor's protocol ID
- PRIC
- Status last verified
- Jan 2019
- First submitted
- 28 Dec 2016
- Last updated
- 1 Feb 2019
- 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 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Crossover Study to Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03826485
- Acronym / sponsor ID
- PRIC
- Conditions
- Healthy
- Keywords
- Pranlukast hydrate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- SamA Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 25 Apr 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 1 Feb 2019 (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 Safety, Pharmacokinetic Study of PRIC
Detailed description
- To Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup
- To evaluate the safety and tolerability of PRIC and Pranlukast Dry Syrup
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Drug: PRIC, Drug: Pranlukast hydratePeriod 1: PRIC Period 2: Pranlukast hydrate |
| B group | Experimental | Drug: PRIC, Drug: Pranlukast hydratePeriod 1: Pranlukast hydrate Period 2: PRIC |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 19 to 45 years old healthy male subject at the screening
- Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study
Key exclusion criteria (2 listed)
- Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- Subjects with history of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, ear, nose and throat (ENT), respiratory, musculoskeletal, infectious, gastrointestinal, liver, biliary, endocrine, renal, genitourinary, nervous, psychiatric, blood disorders, tumors, fractures or any other conditions
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 |
|---|---|---|
| PRICAlso: PRIC 50mgPranlukast hydrate 50mg | Drug | A group, B group |
| Pranlukast hydratePranlukast hydrate 225mg/2.25g | Drug | A group, B group |
Primary outcome
Area Under the Curve (AUC) to last time point (t)
Time frame: 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose
Area under the PRIC/Pranlukast dry syrup concentration in blood-time curve from zero to the final
Maximum concentration of drug (Cmax)
Time frame: 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose
The maximum PRIC/Pranlukast dry syrup concentration in blood sampling time t
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- 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 PRIC and Pranlukast hydrate in people with Healthy, run by SamA Pharmaceutical 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 2 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: status not confirmed, as of the sponsor's last update on 1 Feb 2019. 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 the Curve (AUC) to last time point (t) (time frame: 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose). 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 1 Feb 2019.