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To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fed and fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.) | Drug |
| ||
| Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.) |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on AUC and Cmax | 141 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roderick Malone, M.D. | Clinical Research Center (Cincinnati) | Principal Investigator |
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| Drug |
|
| Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista) | Drug |
|
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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