Allergic RhinitisPhase 1NCT01897428
PK Comparisons of Bepotastine Besilate 10 mg and Bepotastine Salicylate 9.64 mg
A Phase 1 study testing Test-Bepotastine salicylate 9.64 mg and Reference-bepotastine besilate 10 mg in people with Allergic Rhinitis and Urticaria, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed bepotastine formulation, bepotastine salicylate, with a conventional formulation, bepotastine besilate, in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis, Urticaria, Pruritus
- What is being tested?
- Test-Bepotastine salicylate 9.64 mg and Reference-bepotastine besilate 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Aug 2011
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- subjects aged between 20 and 45 years
- Body weight > 50 kg (in case of female > 45 kg) with BMI between 18 and 29 kg/m2
- Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations
Who cannot join
- subjects with acute conditions.
- presence of history affecting ADME
- Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
- Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
- Any other acute or chronic disease
- A history of hypersensitivity to bepotastine
Show all 15Show fewer
- A history of alcohol or drug abuse
- Participation in another clinical trial within 2 months
- smoked >10 cigarettes daily
- consumption over 5 glasses daily of beverages containing xanthine derivatives
- use of any medication having the potential to affect the study results within 10 days before the start of the study.
- medication of the inhibitors or inducers of DME including barbiturates within 1 month
- one of abnormal lab findings as like
- c. AST/ALT > UNL (upper normal limit) x 1.5
- Total bilirubin > UNL x 1.5
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dept. of Clinical Pharmacology & Toxicology, Anam Hospital
Seoul, Seoul, 136-705
About this study
Official title: Clinical Trial to Evaluate Pharmacokinetic Characteristics of Belion in Healthy Subjects
To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed bepotastine formulation, bepotastine salicylate, with a conventional formulation, bepotastine besilate, in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.
- Conditions
- Allergic Rhinitis, Urticaria, Pruritus
- Being tested
- Test-Bepotastine salicylate 9.64 mg, Reference-bepotastine besilate 10 mg
- Medical subject headings
- Rhinitis, Allergic, Urticaria, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test-Bepotastine salicylate 9.64 mgDrug
Also called Berion, Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea
Reference-bepotastine besilate 10 mgDrug
Also called Tarion, Manufactured by Dong-A Pharm. Co., Ltd, Seoul, Korea
| Study group | Role | What they receive |
|---|---|---|
| Reference arm | Active comparator | Treated with Reference (bepotastine besilate 10 mg) Receives: Drug: Reference-bepotastine besilate 10 mg |
| Test arm | Experimental | Treated with Test (bepotastine salicylate 9.64 mg) Receives: Drug: Test-Bepotastine salicylate 9.64 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
bepotastine pharmacokinetics: peak plasma concentrations (Cmax)
Measured: 24 hr
Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 24 hr(AUCall)
Measured: 24 hr
Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf)
Measured: 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startApr 2011
- Primary completionMay 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanlim Pharm. Co., Ltd.
- Responsible party
- Principal investigator, Ji-Young Park, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897428
- Sponsor's protocol ID
- HL-BPT-101
- Status last verified
- Mar 2011
- First submitted
- 9 Jul 2013
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim KA, Park JY. Pharmacokinetic comparisons of bepotastine besilate and bepotastine salicylate in healthy subjects. Clin Drug Investig. 2013 Dec;33(12):913-9. doi: 10.1007/s40261-013-0140-7.
PubMed 24105252
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate Pharmacokinetic Characteristics of Belion in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01897428
- Acronym / sponsor ID
- HL-BPT-101
- Conditions
- Allergic Rhinitis, Urticaria, Pruritus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Hanlim Pharm. Co., Ltd.
- Study start
- Apr 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 12 Jul 2013 (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.
To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed bepotastine formulation, bepotastine salicylate, with a conventional formulation, bepotastine besilate, in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference arm | Active comparator | Drug: Reference-bepotastine besilate 10 mgTreated with Reference (bepotastine besilate 10 mg) |
| Test arm | Experimental | Drug: Test-Bepotastine salicylate 9.64 mgTreated with Test (bepotastine salicylate 9.64 mg) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- subjects aged between 20 and 45 years
- Body weight > 50 kg (in case of female > 45 kg) with BMI between 18 and 29 kg/m2
- Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations
Key exclusion criteria (15 listed)
- subjects with acute conditions.
- presence of history affecting ADME
- Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
- Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
- Any other acute or chronic disease
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 |
|---|---|---|
| Test-Bepotastine salicylate 9.64 mgAlso: Berion, Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea | Drug | Test arm |
| Reference-bepotastine besilate 10 mgAlso: Tarion, Manufactured by Dong-A Pharm. Co., Ltd, Seoul, Korea | Drug | Reference arm |
Primary outcome
bepotastine pharmacokinetics: peak plasma concentrations (Cmax)
Time frame: 24 hr
Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 24 hr(AUCall)
Time frame: 24 hr
Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf)
Time frame: 24 hr
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 12 Jul 2013.
- Derived from this study: PubMed 24105252Kim KA, Park JY. Pharmacokinetic comparisons of bepotastine besilate and bepotastine salicylate in healthy subjects. Clin Drug Investig. 2013 Dec;33(12):913-9. doi: 10.1007/s40261-013-0140-7.
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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 Test-Bepotastine salicylate 9.64 mg and Reference-bepotastine besilate 10 mg in people with Allergic Rhinitis and Urticaria, run by Korea University Anam Hospital 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 15 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 12 Jul 2013. 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?
bepotastine pharmacokinetics: peak plasma concentrations (Cmax) (time frame: 24 hr). The study lists 3 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 NCT01897428, which also lists 1 linked publication.
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 Jul 2013.