← Back to Search

Anti-psychotic

Extended-Release Olanzapine for Schizophrenia

Phase 1
Recruiting
Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours after administration of zyprexa
Awards & highlights

Summary

This trial aims to understand how the body processes three different forms of olanzapine and to assess their safety and tolerability. It also seeks to evaluate how ZYPREXA is processed in the body

Who is the study for?
This trial is for adults with schizophrenia or schizoaffective disorder, confirmed by DSM-5 criteria. Participants must maintain their smoking status, weigh over 50 kg with a BMI of 18.5 to 38.0, and agree to inpatient stays. Women must test negative for pregnancy or be sterile/postmenopausal; men must be sterile or use birth control.Check my eligibility
What is being tested?
The study aims to understand how the body processes three different olanzapine formulations used for treating schizophrenia/psychosis. It also assesses the safety and tolerability of these medications over a period of 19 weeks.See study design
What are the potential side effects?
While not specified here, common side effects of olanzapine can include weight gain, drowsiness, increased appetite, restlessness, dry mouth, and constipation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours after administration of zyprexa
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours after administration of zyprexa for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC extrapolated to infinity (AUC0-∞)
Area under the plasma drug concentration-time curve (AUC)
Maximum observed plasma drug concentration (Cmax)
Secondary outcome measures
AUC of ZYPREXA
Apparent plasma terminal elimination rate constant (λz) of ZYPREXA
Cmax of ZYPREXA
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Olanzapine Group CExperimental Treatment2 Interventions
Single-dose injection
Group II: Olanzapine Group BExperimental Treatment2 Interventions
Single-dose injection
Group III: Olanzapine Group AExperimental Treatment2 Interventions
Single-dose injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olanzapine
2005
Completed Phase 4
~5480

Find a Location

Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
251 Previous Clinical Trials
3,485,283 Total Patients Enrolled
5 Trials studying Schizophrenia
1,672 Patients Enrolled for Schizophrenia
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
93 Previous Clinical Trials
38,686 Total Patients Enrolled
5 Trials studying Schizophrenia
1,672 Patients Enrolled for Schizophrenia
~47 spots leftby Dec 2024