Approval Probability
TA Base Rate
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Also known as Fluoxetine Hydrochloride
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 ...