Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Geneva Clomipramine Under Fasting Conditions · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions. |
| 2 | EXPERIMENTAL | Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions. |
| 3 | ACTIVE_COMPARATOR | Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions. |
| Name | Type | Description |
|---|---|---|
| Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions | DRUG | - |
| Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions | DRUG | - |
| Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions | DRUG | - |
Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.
Geneva Clomipramine Under Fasting Conditions is a Phase 1 study formulation of clomipramine hydrochloride 25 mg capsules evaluated in healthy male volunteers under fasting conditions. It falls in the psychiatry therapeutic area and relates to depression. The work was conducted by Novartis AG under the Geneva label.
The Geneva clomipramine hydrochloride 25 mg capsule is studied in relation to depression, the condition listed for the trial. Clomipramine is a small molecule developed by Novartis AG. The Phase 1 work focused on how the Geneva capsule formulation behaves when taken without food.
Novartis AG, which trades under the ticker NVS, is the developer of Geneva Clomipramine Under Fasting Conditions. The product is a 25 mg clomipramine hydrochloride capsule manufactured under the Geneva label and tested against the Basel (Anafranil) reference capsule.
Geneva Clomipramine Under Fasting Conditions is in Phase 1 development. The single registered trial has completed, and no trials are currently active. It is an investigational formulation studied in healthy volunteers rather than an approved product.
One trial has evaluated Geneva Clomipramine Under Fasting Conditions: NCT00913952, titled to demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg clomipramine hydrochloride capsules under fed and fasted conditions. It was a completed Phase 1 study with 18 enrolled healthy male volunteers aged 18 years and older.