Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic/Efficacy

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Schizophrenia
Interventions
DRUG

Risperidone

Oral risperidone was supplied as 2, 3, or 4 mg tablets in blister packs or bottles and taken daily only during the oral dosing periods of the study, days -14 through -8 (if applicable), days -7 through -1, and days 85 through 87.

DRUG

RBP-7000

RBP-7000 60 mg, 90 mg, and 120 mg were a mixture of the ATRIGEL® Delivery System and 60 mg, 90 mg, or 120 mg risperidone, respectively. Treatment was delivered as subcutaneous injections on study days 1, 29 and 57.

Trial Locations (2)

72211

Woodland International Research Group, Inc., Little Rock

90806

Ocean View Psychiatric Health Facility, Long Beach

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Indivior Inc.

INDUSTRY

NCT01677377 - Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic/Efficacy | Biotech Hunter | Biotech Hunter