Safety, Tolerability, and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Iloperidone, Depot, Injection
Eligibility Criteria
Inclusion Criteria:
- Patients with schizophrenia that have been stable for 3 months.
Exclusion Criteria:
- Women who can become or are currently pregnant or lactating.
- Hypersensitivity to iloperidone or related drugs.
Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Iloperidone 50 mg crystalline formulation - Phase A
Iloperidone 125 mg crystalline formulation - Phase A
Iloperidone 250 mg crystalline formulation - Phase B
Iloperidone 250 mg microparticle formulation - Phase B
Iloperidone 250 mg microparticle formulation - Phase C
Iloperidone 500 mg microparticle formulation - Phase C
Iloperidone 625 mg microparticle formulation - Phase C
Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.