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| Name | Class |
|---|---|
| Hanlim Pharm. Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference arm | Active Comparator | Treated with Reference (bepotastine besilate 10 mg) |
|
| Test arm | Experimental | Treated with Test (bepotastine salicylate 9.64 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test-Bepotastine salicylate 9.64 mg | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| bepotastine pharmacokinetics: peak plasma concentrations (Cmax) | 24 hr | |
| Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 24 hr(AUCall) | 24 hr | |
| Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf) | 24 hr |
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Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Clinical Pharmacology & Toxicology, Anam Hospital | Seoul | Seoul | 136-705 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24105252 | Derived | 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. |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D014581 | Urticaria |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Reference-bepotastine besilate 10 mg | Drug |
|
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |