Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
New formulation, Current formulation · 1 trial · 1 indication
| 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-...
GSK561679 is an investigational drug being studied for use in depressive disorder and anxiety disorders. It was evaluated in a Phase 1 clinical trial in healthy volunteers to investigate its effects on brain activation during emotional processing. The drug is still in clinical development and has not been approved by regulatory authorities.
GSK561679 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company conducted Phase 1 clinical trials to study the drug's effects in healthy volunteers and its potential use in psychiatric conditions such as depressive disorder and anxiety disorders.
GSK561679 is in Phase 1 clinical development. It has completed Phase 1 trials, including a study on brain activation during emotional processing in healthy volunteers. As an investigational drug, it is not yet approved and remains in early-stage clinical testing.
GSK561679 has been studied in Phase 1 clinical trials, including NCT00513565, which examined its effects on brain activation during emotional processing in healthy volunteers with depressive disorder and anxiety disorders. This trial was completed in the United States with 22 female participants.
GSK561679 is not the same as Paxil CR or Secotex. Paxil CR (paroxetine) and Secotex (tamsulosin) are separate drugs studied in bioequivalence trials listed alongside GSK561679 in the same developer's portfolio. GSK561679 is a distinct investigational compound with its own clinical development program.