A Comparison of the Pharmacokinetics and Safety of Long-acting Injectable Risperidone When Administered to Gluteal or Deltoid Intramuscular Injection Sites in Stable Schizophrenia Patients.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the pharmacokinetics and safety of long-acting
      injectable risperidone, an atypical antipsychotic medication used for the treatment of
      patients with schizophrenia, when it is administered as an intramuscular injection via the
      deltoid muscle, compared with intramuscular injection via the gluteal muscle.
    

Detailed description: 
      This is a randomized, open label, single dose, multicenter, 2-way crossover study comprising
      a screening phase, 2 open-label treatment periods, and end-of-study evaluations. The study
      population will comprise patients with chronic stable schizophrenia. Patients will be allowed
      to continue on their existing oral antipsychotic treatment throughout the study, if not
      receiving disallowed mediations, per protocol. Patients will be randomly allocated to receive
      treatment in 1 of 2 panels. In each panel, patients will receive a single intramuscular
      injection of long-acting injectable risperidone in each treatment period, in a 2-way
      crossover design. In Panel I, patients will receive 25 mg long-acting injectable risperidone
      via the gluteal muscle and 37.5 mg long-acting injectable risperidone via the deltoid muscle
      during the study period. In Panel II, patients will receive 50 mg long-acting injectable
      risperidone via the gluteal muscle and 50 mg long-acting injectable risperidone via the
      deltoid muscle. There will be a washout period of 85 days between each administration of
      study drug. The primary outcome will be comparison of the pharmacokinetic parameters area
      under the curve (AUC) and peak plasma concentration (Cmax) for 37.5 mg deltoid versus 25 mg
      gluteal, and for 50 mg deltoid versus 50 mg gluteal. Safety will be assessed at screening,
      throughout the open-label treatment phase, and at the end of study or early withdrawal using
      a combination of adverse events (including occurrence of extrapyramidal symptoms as assessed
      by the Extrapyramidal Symptoms Rating Scale), clinical laboratory tests (hematology, serum
      chemistry, urinalysis, and pregnancy testing), vital signs, physical examinations,
      electrocardiograms, and injection site evaluation. The study hypothesis is that intramuscular
      injections of long-acting injectable risperidone via the gluteal and deltoid sites will be
      bioequivalent routes of administration, as measured by peak and total drug concentrations in
      the plasma, and that the safety and tolerability profiles of the 2 injection sites will be
      comparable. The patients will receive a single injection of long--acting injectable
      risperidone (25 mg, 37.5 mg or 50 mg) in their gluteal or deltoid muscle in 2 treatment
      periods.
    

Intervention name(s): Risperidone long-acting injectable
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Risperidone; Long-acting injectable; Intramuscular injection; Pharmacokinetics