NCT01067807

Proellex Pharmacokinetics Bridging Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	25 mg Proellex	25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) \[Original\], single dose
DRUG	25 mg Proellex	25 mg - given as one 25 mg capsule (coated with microcrystalline cellulose, new formulation) (coated), single dose
DRUG	25 mg Proellex	25 mg - given as one 25 mg capsule (blended with microcrystalline cellulose, new formulation) \[Blended\], single dose
DRUG	50 mg Proellex	50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) \[Blended\], single dose

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2010-02-12
• Last updated: 2014-07-08

Locations

1 site across 1 country: United States