- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01897428
PK Comparisons of Bepotastine Besilate 10 mg and Bepotastine Salicylate 9.64 mg
July 11, 2013 updated by: Ji-Young Park, Korea University Anam Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 136-705
- Dept. of Clinical Pharmacology & Toxicology, Anam Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Reference arm
Treated with Reference (bepotastine besilate 10 mg)
|
Other Names:
|
Experimental: Test arm
Treated with Test (bepotastine salicylate 9.64 mg)
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
bepotastine pharmacokinetics: peak plasma concentrations (Cmax)
Time Frame: 24 hr
|
24 hr
|
Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 24 hr(AUCall)
Time Frame: 24 hr
|
24 hr
|
Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf)
Time Frame: 24 hr
|
24 hr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
July 9, 2013
First Submitted That Met QC Criteria
July 11, 2013
First Posted (Estimate)
July 12, 2013
Study Record Updates
Last Update Posted (Estimate)
July 12, 2013
Last Update Submitted That Met QC Criteria
July 11, 2013
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Skin Diseases, Vascular
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Skin Manifestations
- Rhinitis
- Rhinitis, Allergic
- Pruritus
- Urticaria
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Anti-Allergic Agents
- Bepotastine besilate
- Salicylates
Other Study ID Numbers
- HL-BPT-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Allergic Rhinitis
-
Universitaire Ziekenhuizen KU LeuvenAZ Sint-Jan AVRecruitingPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis | Local Allergic RhinitisBelgium
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
ALK-Abelló A/SCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Humanis Saglık Anonim SirketiCompletedPerennial Allergic Rhinitis | Seasonal Allergic RhinitisIndia
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
West Penn Allegheny Health SystemPennsylvania Allergy and Asthma Research FoundationCompletedAllergy | Perennial Allergic Rhinitis | Seasonal Allergic RhinitisUnited States
-
Ahn-Gook Pharmaceuticals Co.,LtdSamsung Medical Center; Seoul St. Mary's Hospital; Seoul National University... and other collaboratorsCompletedAllergic Rhinitis | Perennial Allergic Rhinitis | Non-seasonal Allergic RhinitisKorea, Republic of
-
Glenmark Specialty S.A.CompletedSeasonal Allergic Rhinitis (SAR)United States
Clinical Trials on Reference-bepotastine besilate 10 mg
-
Bausch & Lomb IncorporatedCompletedSeasonal Allergic RhinitisUnited States
-
Bausch & Lomb IncorporatedCompletedSeasonal Allergic RhinitisUnited States
-
Bausch & Lomb IncorporatedCompletedConjunctivitis, AllergicUnited States
-
Bausch & Lomb IncorporatedCompletedAllergic ConjunctivitisUnited States
-
North Texas Institute for Clinical TrialsCompletedHistamine Responsive Allergy PatientsUnited States
-
Laboratorios Sophia S.A de C.V.CompletedTolerability | Safety | Ocular Surface | Ocular ComfortMexico
-
Southern California College of Optometry at Marshall...CompletedAllergic ConjunctivitisUnited States
-
Asan Medical CenterCompletedCough | Allergic RhinitisKorea, Republic of
-
Bausch & Lomb IncorporatedCompletedAllergic ConjunctivitisUnited States
-
Bausch & Lomb IncorporatedCompleted