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This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of either 1 or 6 days of dosing with two different formulations of Proellex for vaginal administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 8 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. Subjects will receive a single dose of Treatment A or daily dosing with Treatment B for 6 days. After a 7-day washout period subjects will receive the alternative treatment. On the day of treatment with Treatment A and on the first and last days of treatment with Treatment B subjects will remain in the clinic overnight and undergo 32-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 4, 8, 12, 16, 20, 24, 28 and 32 hours after administration of study drug. For Treatment B study drug will be administered in the clinic each day after a trough blood sample has been drawn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proellex Schedule A | Experimental | Proellex vaginal capsule, 12 mg, once a day for up to 7 days |
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| Proellex Schedule B | Experimental | Proellex vaginal capsule, 12 mg, once a day for up to 7 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proellex Formulation A | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | To determine and compare the maximum measured plasma concentration over the final dosing interval(Cmax) of two formulations of 12 mg Proellex administered vaginally in female healthy volunteers once daily for up to 7 days. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| Sponsor corporate website | View source |
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| Proellex Formulation B |
| Drug |
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