NCT00749879

Crossover Study of the Safety and PK Properties of Proellex®

A Phase I, Open-Label, Randomized, Single-Center, Unblinded, Single-Dose, Five-Way Crossover Study of the Safety and PK Properties of Proellex®

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 34 Years
• Healthy volunteers: Accepted

Summary

Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.

Detailed description

This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50 mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers in the fed and fasting states.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Proellex	25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting

Timeline

• Start date: 2008-08-11
• Primary completion: 2008-10-23
• Completion: 2008-10-23
• First posted: 2008-09-09
• Last updated: 2019-04-29
• Results posted: 2019-04-29

Locations

1 site across 1 country: United States