Conditions: Pharmacokinetics
Keywords: PK Pharmacokinetics
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 17
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose

Fed State arm 2: 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose

Fasting State arm 3: 2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose

Fed State arm 4: 2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose

Fasting State arm 5: 2, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose

Fasting State

Interventions: intervention 1: Proellex
Intervention descriptions: intervention 1: 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

Protocol document: