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This is a single center, single blind, single dose, randomized, partial cross-over study to confirm bioequivalence between levocetirizine and cetirizine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levocetirizine | Other | Study Drug |
|
| cetirizine | Other | Study Drug |
|
| placebo | Other | Study Drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levocetirizine | Drug | levocetirizine |
| |
| cetirizine |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-48 of levocetirizine | Area Under the time-concentlation curve | predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose |
| Cmax of levocetirizine | maximum concentration | predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse events | predose,1,24 48 hours post-dose | |
| Changes in clinical laboratory tests | predose,24,48 hours post-dose | |
| Changes in vital signs |
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Inclusion Criteria:
Japanese healthy male subjects aged between 20 and 64 years of age inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, and other tests.
Body weight ≥ 50 kg and BMI within the range 18.50-25.00 kg/m2 inclusive.
Non-smokers (at least 6 months).
Clinical laboratory tests data obtained at screening meet the following:
AST(GOT), ALT(GPT), total-bilirubin, BUN, creatinine, uric acid,: below the upper normal range
Normal 12-lead EGC finding at screening; QTc interval <450msec
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Kagoshima | 890-0081 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Hiroko Ino, Shigeru Nohda, Shuji Miki, Kastutoshi Hara, Toshiyasu Hirama. Comparison of levocetirizine pharmacokinetics, following a single dose of levocetirizine alone or as cetirizine in Japanese healthy male volunteers . [Jpn J Clin Pharmacol Therapeut]. 2010;41(6):309. |
| Label | URL |
|---|---|
| Results for study 111580 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C472067 | levocetirizine |
| D017332 | Cetirizine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
cetiridine |
|
| placebo | Drug | placebo |
|
| predose,1,24,48 hours post-dose |
| Changes in 12-lead ECG. | predose,1,24,48 hours post-dose |