Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01247272 | 90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions | PHASE1 | COMPLETED | 26 | — | — | May 1, 2001 | Jul 1, 2001 | Feb 21, 2011 | 1 | United States |
| NCT01247285 | 90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions | PHASE1 | COMPLETED | 26 | — | — | May 1, 2001 | Jul 1, 2001 | Feb 21, 2011 | 1 | United States |
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 ...