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Also known as Fluoxetine Hydrochloride, PROZAC WEEKLY®
Fluoxetine · 2 trials · 1 indication
Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).
Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).
| Arm | Type | Description |
|---|---|---|
| Reference Listed Drug | ACTIVE_COMPARATOR | 90 mg PROZAC WEEKLY® Capsules (Eli Lilly) |
| Investigational Test Product | EXPERIMENTAL | 90 mg Fluoxetine Hydrochloride Capsules (Teva) |
| Name | Type | Description |
|---|---|---|
| Fluoxetine Hydrochloride | DRUG | 90 mg Capsules |
| PROZAC WEEKLY® | DRUG | 90 mg Capsules |
Inclusion Criteria: * Screening Demographics: All volunteers selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The weight range will not exceed + 15% for height and body frame as per Desirable Weights for Men - 1983 Metropolitan Height and Weight ...
Fluoxetine is a small molecule drug candidate that Teva Pharmaceutical Industries Limited is developing. It is also known as fluoxetine hydrochloride. The program is in Phase 1 clinical development, and the specific therapeutic indication has not been disclosed.
Fluoxetine targets SLC6A4, which is the serotonin transporter. It acts as an inhibitor of this target. SLC6A4 inhibition is the mechanism associated with this small molecule drug candidate.
Teva Pharmaceutical Industries Limited is developing Fluoxetine. The company trades under the ticker TEVA. Teva is the sponsor associated with the clinical development program for this drug candidate.
Fluoxetine is in Phase 1 clinical development. It is an investigational drug candidate and is not approved. Two Phase 1 trials have been completed, with no active trials currently listed.
Fluoxetine has been studied in two completed Phase 1 trials: NCT01247285, which evaluated 90 mg fluoxetine hydrochloride capsules under non-fasting conditions, and NCT01247272, which evaluated the same capsules under fasting conditions. Both enrolled 26 healthy volunteers in the United States.
Yes, Fluoxetine Hydrochloride is another name for Fluoxetine. The two names refer to the same drug candidate developed by Teva Pharmaceutical Industries Limited.