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• To determine and compare the pharmacokinetics (PK) of 3 doses of 25 mg Androxal in elderly healthy adult male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 70 years or older | Experimental | Non-smoking healthy adult males >or equal to 70 years of age. |
|
| Under 60 years of age | Experimental | Non-smoking healthy adult males<60 years of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Androxal 25 mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - The Cmax will be calculated. | 4 days | |
| Pharmacokinetics - The Tmax will be calculated. | 4 days | |
| Pharmacokinetics - The AUC0-24 will be calculated. | 4 days | |
| Pharmacokinetics - the AUC0-∞ will be calculated. | 4 days | |
| Pharmacokinetics - The t½ will be calculated. | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Incidence of adverse events | 4 days | |
| Safety -Mean change from baseline in laboratory values | 4 days | |
| Safety - Mean change from baseline in vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | United States |
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| ID | Term |
|---|---|
| D064695 | Enclomiphene |
| ID | Term |
|---|---|
| D002996 | Clomiphene |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| 4 days |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |