At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Proellex 25 mg formulation A +1 moredrug
Likely dose
Proellex 25 mg formulation Afrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Proellex® Pharmacokinetic Bridging Study II
In Brief
A Phase 1 clinical trial evaluating Proellex 25 mg formulation A and Proellex 25 mg formulation B for Healthy. Completed, enrolled 12 participants across 1 site.
Detailed Summary
An open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2008
Enrollment StartFeb 2008
Primary CompletionApr 2008
TodayJul 2026
First PostedFeb 21, 2008
Enrollment StartFeb 29, 2008
Primary CompletionApr 30, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 18.4 years ago
Interventions
Proellex 25 mg formulation Adrug
One Proellex 25 mg formulation A capsule
Proellex 25 mg formulation Bdrug
One 25 mg Proellex capsule formulation B administered both fed and fasted