Proellex Pharmacokinetics Bridging Study

Proellex Pharmacokinetics Bridging Study

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations (24 and 50 mg dose). Blood was collected pre-dose, at specified intervals and 24 hours post dose. Each dose was separated by at least one week interval from the previous dose.

Inclusion Criteria:

• Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the clinical Investigator
• Subject was willing to remain in the clinic for the screening visit; and for the treatment visits (day -1, day of treatment and day 1; approximately 36 hrs per treatment visit)

Exclusion Criteria:

• Post-menopausal women,
• Subject with documented endometriosis
• Subject with known uterine fibroids or vaginal polyps