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Trial · NCT06319170

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation)Cohort 1: Olanzapine (Fast-D)39.26Geometric Coefficient of Variation 45.10nanograms (ng)/milliliter (mL)
Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation)Cohort 2: Olanzapine (To-be-marketed)35.62Geometric Coefficient of Variation 67.55nanograms (ng)/milliliter (mL)
Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation)Cohort 3: Olanzapine (Slow-C)29.68Geometric Coefficient of Variation 50.13nanograms (ng)/milliliter (mL)
Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation)Cohort 1: Olanzapine (Fast-D)20994.08Geometric Coefficient of Variation 33.77hours*ng/mL
Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation)Cohort 2: Olanzapine (To-be-marketed)20185.90Geometric Coefficient of Variation 47.35hours*ng/mL
Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation)Cohort 3: Olanzapine (Slow-C)18461.94Geometric Coefficient of Variation 35.44hours*ng/mL
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation)Cohort 1: Olanzapine (Fast-D)21703.07Geometric Coefficient of Variation 35.06hours*ng/mL
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation)Cohort 2: Olanzapine (To-be-marketed)22146.09Geometric Coefficient of Variation 42.77hours*ng/mL
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation)Cohort 3: Olanzapine (Slow-C)19011.66Geometric Coefficient of Variation 37.21hours*ng/mL
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 FormulationsCohort 1: Olanzapine (Fast-D)9Participants
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 FormulationsCohort 2: Olanzapine (To-be-marketed)12Participants
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 FormulationsCohort 3: Olanzapine (Slow-C)9Participants
Number of Participants With at Least 1 Serious Adverse Event (SAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine FormulationsCohort 1: Olanzapine (Fast-D)0Participants
Number of Participants With at Least 1 Serious Adverse Event (SAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine FormulationsCohort 2: Olanzapine (To-be-marketed)1Participants
Number of Participants With at Least 1 Serious Adverse Event (SAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine FormulationsCohort 3: Olanzapine (Slow-C)0Participants
Cmax of ZYPREXA (Immediate-release Formulation)ZYPREXA11.09Geometric Coefficient of Variation 82.89ng/mL
AUC0-t of ZYPREXA (Immediate-release Formulation)ZYPREXA264.22Geometric Coefficient of Variation 48.14hours*ng/mL
Apparent Plasma Terminal Elimination Rate Constant (λz) of ZYPREXA (Immediate-release Formulation)ZYPREXA0.0159Standard Deviation 0.003811/hour

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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