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    The value on the web page has changed from 'Show more Show more Revision: v2.9.0' to 'Show less MedlinePlus Genetics related topics: Attention-deficit/hyperactivity disorder Drug Information available for: Lisdexamfetamine Lisdexamfetamine dimesylate FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Crossover Assignment Masking : Double Arms and Interventions Intervention/Treatment Drug : NRP104 Primary Outcome Measures Outcome Measure Measure Description Time Frame Pharmacodynamic (PD) Parameters: The following parameters will be measured at fixed time intervals post drug and used to compare the effects of various doses of NRP104 with placebo and d-amphetamine sulfate for pharmacodynamic equivalence: (1) Maximum liking scale scores for euphoria measured by DRQS and DRQO (2) Maximum disliking scale scores for dysphoria measured by DRQS and DRQO (3) Maximum scores on the MBG, BG and Amphetamine scales of the ARCI (4) Maximum supine systolic and diastolic blood pressure changes from baseline (5) Maximum orthostatic pulse increases from baseline (6) Spontaneous reports of discomforting subjective effects (7) Adverse events, laboratory tests, physical examination, vital signs and ECG will be collected to assess the safety and tolerability of NRP104. Pharmacokinetic (PK) Parameters The following parameters will be calculated using non-compartmental analysis for d-amphetamine and intact NRP104: AUC0-24, Cmax , Tmax. AUC0-24: Area under the drug concentration-time curve from time zero to 24 hours post dose. Cmax: Maximum observed drug concentration from zero hour to 24 hours post dose. Tmax: Time at which Cmax occurs. Keywords Provided by New River Pharmaceuticals d-Amphetamine Attention Deficit Hyperactivity Disorder Attention Deficit Disorders with Hyperactivity Attention Deficit Hyperactivity Disorders Amphetamine Abuse Amphetamine Dependence Amphetamine Addiction Amphetamine Users Drug Abuse Drug Addiction Drug Dependence Drug Habituation Drug Use Disorders Substance Abuse Substance Dependence Substance Use Disorders Drug Usage Substance Addiction Drug Abuse, Intravenous Intravenous Drug Abuse Additional Relevant MeSH Terms Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Chemically-Induced Disorders Hyperkinesis Substance-Related Disorders Amphetamine-Related Disorders Attention Deficit Disorder with Hyperactivity Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Lisdexamfetamine Dimesylate Revision: v2.9.1'. This change represents an update in the information displayed on the webpage regarding the study details, primary outcome measures, and relevant keywords.
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    Check dated 2024-06-25T07:59:19.000Z thumbnail image

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