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This study is designed to show bioequivalence between Current and New formulation of Aciclovir cream 5% in keratin layer of the epidermis in Japanese Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving new formulation in blank test group | Experimental | Eligible subjects will receive acyclovir cream 5 % following single topical application. |
|
| Subjects receiving current formulation in blank test group | Active Comparator | Eligible subjects will receive acyclovir cream 5 % following single topical application. |
|
| Subjects receiving new formulation in pre-test group | Experimental | Eligible subjects will receive acyclovir cream 5 % following single topical application. |
|
| Subjects receiving current formulation in pre-test group | Active Comparator | Eligible subjects will receive acyclovir cream 5 % following single topical application. |
|
| Subjects receiving new formulation in main-test group | Experimental | Eligible subjects will receive acyclovir cream 5 % following single topical application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New formulation | Drug | New formulation of Aciclovir Cream 5% scheduled to be substituted to Current formulation in Japan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream | One day |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the safety and tolerability of New and Current formulation of Aciclovir Cream 5% following single topical application in healthy Japanese male subjects | One day |
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Inclusion Criteria:
Healthy subjects are defined as individuals who are free from clinically significant disease as determined by their medical history, physical examination, clinical laboratory examinations, vital sign, 12-lead ECG, immunology tests and urinary drug screen test.
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 | Tokyo | 160-0017 | Japan |
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| Label | URL |
|---|---|
| Results for study ZVC111449 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D006560 | Herpes Labialis |
| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| Subjects receiving current formulation in main-test group | Active Comparator | Eligible subjects will receive acyclovir cream 5 % following single topical application. |
|
| Current formulation | Drug | Current formulation of Aciclovir Cream 5% in Japan |
|
| D007239 |
| Infections |
| D017193 | Skin Diseases, Viral |
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |