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Trial · NCT00247572

Registered outcomes19

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

ListOutcomeTime frameDescription
PrimaryPharmacodynamic (PD) Parameters:
PrimaryThe following parameters will be measured at fixed time intervals post drug and used to compare the
Primaryeffects of various doses of NRP104 with placebo and d-amphetamine sulfate for pharmacodynamic
Primaryequivalence:
Primary(1) Maximum liking scale scores for euphoria measured by DRQS and DRQO
Primary(2) Maximum disliking scale scores for dysphoria measured by DRQS and DRQO
Primary(3) Maximum scores on the MBG, BG and Amphetamine scales of the ARCI
Primary(4) Maximum supine systolic and diastolic blood pressure changes from baseline
Primary(5) Maximum orthostatic pulse increases from baseline
Primary(6) Spontaneous reports of discomforting subjective effects
Primary(7) Adverse events, laboratory tests, physical examination, vital signs and ECG will be collected to
Primaryassess the safety and tolerability of NRP104.
PrimaryPharmacokinetic (PK) Parameters
PrimaryThe following parameters will be calculated using non-compartmental analysis for d-amphetamine and
Primaryintact
PrimaryNRP104: AUC0-24, Cmax , Tmax.
Primary• AUC0-24: Area under the drug concentration-time curve from time zero to 24 hours post dose.
Primary• Cmax: Maximum observed drug concentration from zero hour to 24 hours post dose.
Primary• Tmax: Time at which Cmax occurs.

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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