The primary objective of the study is to characterize the pharmacokinetics of 3 formulations of olanzapine. A secondary objective is to evaluate the safety and tolerability of 3 formulations of olanzapine. Another secondary objective is to characterize the pharmacokinetics of ZYPREXA. The planned duration of the study for each participant is 19 weeks.
All participants received immediate-release ZYPREXA and then were randomized into 1 of 3 extended-release olanzapine formulations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Powder and vehicle for injectable suspension
IntraMuscular Injection
Teva Investigational Site 15730
Los Alamitos, California, United States
Teva Investigational Site 15727
Hollywood, Florida, United States
Teva Investigational Site 15729
Atlanta, Georgia, United States
Teva Investigational Site 15728
Decatur, Georgia, United States
Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation)
Time frame: Randomization Day 1 to 84 days after randomization
Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation)
Time frame: Randomization Day 1 to 84 days after randomization
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation)
Time frame: Randomization Day 1 to 84 days after randomization
Number of Participants With at Least 1 Treatment-emergent Adverse Event (TEAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A TEAE was defined as an AE that occurred after the first dose of study drug administration through the end of trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Time frame: Randomization Day 1 through Randomization Day 29
Number of Participants With at Least 1 Serious Adverse Event (SAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations
The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Time frame: Randomization Day 1 through Randomization Day 29
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Teva Investigational Site 15726
Marlton, New Jersey, United States
Cmax of ZYPREXA (Immediate-release Formulation)
Time frame: Up to 24 hours after administration of ZYPREXA (Day 4)
AUC0-t of ZYPREXA (Immediate-release Formulation)
Time frame: Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13)
Apparent Plasma Terminal Elimination Rate Constant (λz) of ZYPREXA (Immediate-release Formulation)
Time frame: Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13)