A Study to Explore Plasma Levels of CONCERTA, Ritalin-SR and Novo-Methylphenidate ER-C in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of blood plasma levels of methylphenidate in healthy volunteers over a 24
      hour period after they take this medication.
    

Detailed description: 
      The purpose of this study is to measure the blood plasma concentrations of methylphenidate in
      healthy volunteers for 24 hours after they take three different long acting methylphenidate
      products. This is a single-centre, randomized (subjects will be assigned a treatment sequence
      based on chance), open-label (all people involved know the identity of the intervention),
      single-dose, three-way crossover study (participants may receive different interventions
      sequentially during the trial) in 30 healthy adult volunteers. Study drug will be taken by
      mouth with 240mL of room temperature noncarbonated water. Blood sampling will be done via
      indwelling catheter at pre dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 11,
      12, 14, 16, 20 and 24 hours post dose. An indwelling venous catheter is put in place for the
      24 hour period to minimize the discomfort of frequent blood sampling. Each patient will
      receive one dose of each treatment under study in a specific sequence and at specified
      timepoints. The treatments are: one 54mg Concerta tablet, one 54 mg Novo-methylphenidate ER-C
      tablet, and 3x20mg Ritalin-SR tablets. The methylphenidate plasma concentrations observed
      during the 24 hour post-dose time period will be compared for each volunteer and across all
      volunteers. Adverse events will be monitored from the time the informed consent is signed
      until the patient completes the last study-related procedure. The investigator must follow
      all adverse events reported to the investigator to satisfactory resolution or until reaching
      a clinically stable endpoint. Vital signs will be taken at study entry and before each dose -
      as well as at specific timepoints over the 24 hour sample period. Clinical labs and EKG will
      be done at screening and at each 24 hour timepoint.

      The official study title is as follows: A Randomized, Open-label, Single-dose, Three-way
      Crossover Study to Determine the Relative Pharmacokinetic Profile of Oral Doses of CONCERTA
      Tablets, Ritalin-SR Tablets and Novo-Methylphenidate ER-C Tablets Under Fasted Condition in
      Healthy Subjects. Methylphenidate is indicated for the treatment of attention deficient
      hyperactivity disorder in adults, adolescents and children. Each volunteer will receive one
      54-mg CONCERTA tablet(once), one 54-mg Novo-Methylphenidate ER-C tablet (once) and three 20mg
      Ritalin-SR tablets (once) at specified time points in the study. Tablets will be administered
      as a single oral dose under fasted (minimum 10 hour fast) conditions. Study drug will be
      administered orally with 240 mL of room temperature noncarbonated water.
    

Intervention name(s): Ritalin-SR; Concerta; Novo-Methylphenidate ER-C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3-20mg tablets, once; one 54mg tablet, once; one 54mg tablet, once
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetic; Methylphenidate; Novo-methylphenidate ER-C; Ritalin-SR; CONCERTA; Plasma profile