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Fluoxetine Under Fasting Conditions · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.) |
| 2 | EXPERIMENTAL | Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.) |
| 3 | ACTIVE_COMPARATOR | Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista) |
| Name | Type | Description |
|---|---|---|
| Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.) | DRUG | - |
| Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.) | DRUG | - |
| Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista) | 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.
Fluoxetine Under Fasting Conditions is a Phase 1 clinical study formulation of fluoxetine hydrochloride 20 mg capsules, developed by Novartis AG (ticker NVS). It is a small molecule in the psychiatry therapeutic area, studied for depression. The trial evaluated the relative bioavailability of Geneva and Dista (Prozac) 20 mg fluoxetine hydrochloride capsules in healthy adult males under fed and fasted conditions.
Fluoxetine Under Fasting Conditions targets SLC6A4, the serotonin transporter. It acts as an inhibitor of this target. By inhibiting SLC6A4, the drug increases serotonin levels in the synaptic cleft, which is the mechanism underlying its use in depression.
Novartis AG, which trades under the ticker NVS, is the developer of Fluoxetine Under Fasting Conditions. The asset is a fluoxetine hydrochloride 20 mg capsule formulation studied under fasting conditions.
Fluoxetine Under Fasting Conditions is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single Phase 1 trial has been completed, with no active trials ongoing.
Fluoxetine Under Fasting Conditions has been studied in one completed Phase 1 trial, NCT00913588. The trial enrolled 24 healthy adult male volunteers and compared the relative bioavailability of Geneva and Dista (Prozac) 20 mg fluoxetine hydrochloride capsules under fed and fasted conditions. It was randomized and active-controlled.