Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PROZAC WEEKLY · 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 ...
PROZAC WEEKLY is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and it is not yet approved for any indication.
PROZAC WEEKLY is being studied for use in healthy volunteers. It is currently in Phase 1 clinical trials, which are designed to evaluate the drug's safety and pharmacokinetics in healthy individuals. The drug is not yet approved for any specific medical condition.
PROZAC WEEKLY is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker symbol TEVA. The drug is currently in Phase 1 clinical development.
PROZAC WEEKLY is in Phase 1 clinical development. It has completed two Phase 1 trials, both of which were conducted in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
PROZAC WEEKLY has completed two Phase 1 clinical trials: NCT01247272, a study of 90 mg fluoxetine hydrochloride capsules under fasting conditions, and NCT01247285, a study of the same capsules under non-fasting conditions. Both trials enrolled 26 healthy volunteers each in the United States.
PROZAC WEEKLY is a formulation of fluoxetine hydrochloride, as indicated by the clinical trial titles for the 90 mg capsules. It is being developed by Teva Pharmaceutical Industries Limited and is currently in Phase 1 clinical trials.