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Trial · NCT03292016

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMaximum Observed Plasma Concentration (Cmax)Day 1Dose normalized maximum observed plasma concentration (Cmax)
PrimaryObserved Time of the Maximum Concentration (Tmax)Day 1Time from dosing to Cmax, observed by inspection of individual subject plots of plasma concentration versus time.
PrimaryArea Under the Concentration- Time Curve (AUC Last)Day 1area under the concentration-time curve from time zero to the last measurable plasma concentration-time curve using the linear up log down trapezoidal rule.
PrimaryArea Under the Concentration- Time Curve (AUC Inf)Day 1area under the concentration-time curve from time zero extrapolated to infinity using the linear up log down trapezoidal rule.
PrimaryMean Residence Time (MRT)Day 1Mean residence time during one dosing interval calculated using the following equation: MRT = AUMCinf/AUC inf. AUMCinf is the area under the first moment (time.plasma concentration vs. time) curve.
PrimaryMetabolite/Parent (M/P) Drug Concentration Ratio -CmaxDay 1Metabolite (apomorphine sulfate) to Parent exposure ratio, Cmax, corrected for molecular weight differences.
PrimaryApparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F)Day 1Apparent total clearance of the drug from plasma extravascular administration, calculated as Dose/AUCinf.
PrimaryApparent Volume of Distribution After Non-intravenous Administration (V/F)Day 1Apparent volume of distribution after extravascular administration, calculated as Dose/(AUCinf \* λz).
PrimaryTerminal-phase Half-life (t½)Day 1Terminal phase half-life, as calculated by the following equation: t½ = ln(2)/λz.
PrimaryTerminal-phase Rate Constant ( λz)Day 1
Apparent terminal elimination rate constant, determined by log linear regression of the plasma concentration versus time data that was judged to be in the log-linear elimination phase. At least 3 data points in the terminal phase will be used in the determination of the rate constant.
PrimaryMetabolite/Parent (M/P) Drug Concentration Ratio -AUC LastDay 1Metabolite (apomorphine sulfate) to Parent exposure ratio, AUClast, corrected for molecular weight differences.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license 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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