Lithium Drug-Drug Interaction Study With Lurasidone HCl
|ClinicalTrials.gov Identifier: NCT01074073|
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : September 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Lurasidone HCl||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, 2-Period, Sequential, Drug-Drug Interaction Study To Determine The Effect Of Lithium 600 Mg BID On The Safety And Pharmacokinetics Of Lurasidone 120 Mg QD In Patients With Schizophrenia Or Schizoaffective Disorder|
|Study Start Date :||August 2008|
|Primary Completion Date :||October 2008|
|Study Completion Date :||October 2008|
Drug: Lurasidone HCl
lurasidone HCl 40 mg tablets administered orally as three tablets (120 mg) once a day (QD).
Lithium 300 mg capsules administered orally as two capsules (600 mg) twice a day (BID).
On dosing days, breakfast will be served 30 minutes prior to the planned dosing time. Patients must consume the breakfast within 30 minutes or less. Dosing will take place 30 minutes after the start of breakfast.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074073
|United States, California|
|Culver City, California, United States, 90232|
|Principal Investigator:||Marina Bussel, MD||CCT/Parexel|