Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00711776 | Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers | PHASE1 | COMPLETED | 27 | — | — | Apr 10, 2008 | Aug 17, 2008 | Aug 31, 2018 | 1 | Japan |
| Arm | Type | Description |
|---|---|---|
| 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. |
| Subjects receiving current formulation in main-test group | ACTIVE_COMPARATOR | Eligible subjects will receive acyclovir cream 5 % following single topical application. |
| Name | Type | Description |
|---|---|---|
| New formulation | DRUG | New formulation of Aciclovir Cream 5% scheduled to be substituted to Current formulation in Japan |
| Current formulation | DRUG | Current formulation of Aciclovir Cream 5% in Japan |
Inclusion Criteria: * Healthy Japanese adult males between 20 and 55 years of age, inclusive. 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-...