Rhinitis, Allergic, PerennialPhase 1NCT02682745
Single Dosing Clinical Trial of HL151
A Phase 1 study testing HL151 and TALION tab. in people with Rhinitis, Allergic, Perennial, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after single oral administration of TALION tab, a IR formulation of bepotastine as reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- HL151 and TALION tab.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jan 2016to 12 Feb 2016
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteer in the age of 19-45
- Body weight≥50kg and BMI 18~29 kg/m2
- Subject who sign on an informed consent form willingly
Who cannot join
- Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- Subject with acute disease within 28 days prior to study medication dosing
- Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
- Subject with clinically significant chronic disease
- Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL
- Use of any prescription medication within 14 days prior to study medication dosing
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- Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
- Subject with clinically significant allergic disease
- Subject with known for hypersensitivity reaction to bepotastine
- Subject with any of the following conditions in laboratory test
- AST/ALT > UNL (upper normal limit) x 2
- Total bilirubin > UNL x 2
- Renal failure with CLcr < 50mL/min calculated on Cockcroft-Gault [Cockcroft-Gault GFR = (140-age) * (Wt in kg) / (72 *Cr)]
- SBP<100mmHg or ≥160mmHg, DBP<60mmHg or ≥100mmHg
- QTc>440msec on ECG
- Serum potassium < 3.5 mEq/L or > 5.5 mEq/L
- Immunological incompetence, immune deficiency or taking immunosuppressants
- Subject who cannot take standard meal
- Subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing
- Subject with blood transfusion within 30days prior to study medication dosing
- Participation in any clinical investigation within 90days prior to study medication dosing
- Continued excessive use of caffeine (caffeine >five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette >10 cigarettes per day)
- Subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
- Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
- Subject who are not using adequate means of contraception
- Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption
- Subject with history of drug abuse or drug addiction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dosing Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of HL151 Formulation in Healthy Male Subjects
The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after single oral administration of TALION tab, a IR formulation of bepotastine as reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- HL151, TALION tab.
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL151Drug
Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal
TALION tab.Drug
Reference drug: TALION tab, 1T, every 12 hours, oral administration
| Study group | Role | What they receive |
|---|---|---|
| R-T1-T2 | Experimental | First period: administration of reference drug, Second period: administration of test drug l, Third period : administration of test drug ll Receives: Drug: HL151; Drug: TALION tab. |
| R-T2-T1 | Experimental | First period : administration of reference drug, Second period : administration of test drug ll, Third period : administration of test drug l Receives: Drug: HL151; Drug: TALION tab. |
| T1-T2-R | Experimental | First period : administration of test drug l, Second period : administration of test drug ll, Third period : administration of reference drug Receives: Drug: HL151; Drug: TALION tab. |
| T1-R-T2 | Experimental | First period : administration of test drug l, Second period : administration of reference drug, Third period : administration of test drug ll Receives: Drug: HL151; Drug: TALION tab. |
| T2-R-T1 | Experimental | First period : administration of test drug ll, Second period : administration of reference drug, Third period : administration of test drug l Receives: Drug: HL151; Drug: TALION tab. |
| T2-T1-R | Experimental | First period : administration of test drug ll, Second period : administration of test drug l, Third period : administration of reference drug Receives: Drug: HL151; Drug: TALION tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)
Measured: 24 hours after single administration
Peak Plasma Concentration (Cmax)
Measured: 24 hours after single administration
Secondary outcomes (1)
Number of participants with adverse events
Measured: Participants will be followed for the duration of study medication dosing days and hospital stay, and follow-up period for maximum 5 days from the discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start15 Jan 2016
- Primary completion12 Feb 2016
- Study completion12 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682745
- Sponsor's protocol ID
- HL-BPSR-101
- Status last verified
- Aug 2018
- First submitted
- 3 Feb 2016
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dosing Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of HL151 Formulation in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02682745
- Acronym / sponsor ID
- HL-BPSR-101
- Conditions
- Rhinitis, Allergic, Perennial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 12 Feb 2016 (actual)
- Study completion
- 12 Feb 2016 (actual)
- First posted
- 15 Feb 2016 (estimated)
- 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 assess the pharmacokinetic characteristics of bepotastine after single oral administration of TALION tab, a IR formulation of bepotastine as reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| R-T1-T2 | Experimental | Drug: HL151, Drug: TALION tab.First period: administration of reference drug, Second period: administration of test drug l, Third period : administration of test drug ll |
| R-T2-T1 | Experimental | Drug: HL151, Drug: TALION tab.First period : administration of reference drug, Second period : administration of test drug ll, Third period : administration of test drug l |
| T1-T2-R | Experimental | Drug: HL151, Drug: TALION tab.First period : administration of test drug l, Second period : administration of test drug ll, Third period : administration of reference drug |
| T1-R-T2 | Experimental | Drug: HL151, Drug: TALION tab.First period : administration of test drug l, Second period : administration of reference drug, Third period : administration of test drug ll |
| T2-R-T1 | Experimental | Drug: HL151, Drug: TALION tab.First period : administration of test drug ll, Second period : administration of reference drug, Third period : administration of test drug l |
| T2-T1-R | Experimental | Drug: HL151, Drug: TALION tab.First period : administration of test drug ll, Second period : administration of test drug l, Third period : administration of reference drug |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteer in the age of 19-45
- Body weight≥50kg and BMI 18~29 kg/m2
- Subject who sign on an informed consent form willingly
Key exclusion criteria (27 listed)
- Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- Subject with acute disease within 28 days prior to study medication dosing
- Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
- Subject with clinically significant chronic disease
- Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL
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 |
|---|---|---|
| HL151Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal | Drug | R-T1-T2, R-T2-T1, T1-R-T2, T1-T2-R, T2-R-T1, T2-T1-R |
| TALION tab.Reference drug: TALION tab, 1T, every 12 hours, oral administration | Drug | R-T1-T2, R-T2-T1, T1-R-T2, T1-T2-R, T2-R-T1, T2-T1-R |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: 24 hours after single administration
Peak Plasma Concentration (Cmax)
Time frame: 24 hours after single administration
1 secondary outcome
Number of participants with adverse events
Time frame: Participants will be followed for the duration of study medication dosing days and hospital stay, and follow-up period for maximum 5 days from the discharge
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 17 Aug 2018.
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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 HL151 and TALION tab. in people with Rhinitis, Allergic, Perennial, run by Hanlim Pharm. 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 27 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 17 Aug 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?
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?
Area under the plasma concentration versus time curve (AUC) (time frame: 24 hours after single 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 17 Aug 2018.