Evaluation of Individual Bioequivalence of Gabasandoz® Relative to Neurontin® in Healthy Volunteers
Condition: Epilepsy and Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      The NO SWITCH list is based on the hypothesis that the pharmacokinetic differences between
      different batches of one medicines are smaller than the pharmacokinetic differences between
      two medicines (from a different manufacturer, e.g. brand versus generic medicine). The aim of
      this study is to investigate the hypothesis using gabapentin as test product. Therefore, the
      first objective of this study is to investigate the individual bioequivalence - or
      switchability - of Gabasandoz® 800 mg relative to Neurontin 800 mg®. The second objective is
      to investigate the individual bioequivalence between two different batches of the same
      medicine, for Gabasandoz® 800 mg and Neurontin® 800 mg.
    

Detailed description: 
      At the end of 2011, the Belgian Federal Agency for Medicines and Health Products (FAMHP)
      introduced a list of medicines, called the 'NO SWITCH' list1. This list contains 42 active
      pharmaceutical ingredients with a narrow therapeutic index (i.e. small differences between
      the effective and toxic concentration), very toxic ingredients and all antiepileptics. For
      the active ingredients on the NO SWITCH-list, the FAMHP advises, once treatment is started
      with a medicines from a particular manufacturer, to continue treatment with exactly the same
      medicine (from the same manufacturer). In other words, switching from e.g. Neurontin® 800 mg
      to Gabasandoz® 800 mg during treatment is not recommended. However, switching is possible,
      but only when done carefully and under the supervision of a physician.

      The NO SWITCH list is based on the hypothesis that the pharmacokinetic differences between
      different batches of one medicines are smaller than the pharmacokinetic differences between
      two medicines (from a different manufacturer, e.g. brand versus generic medicine).

      The aim of this study is to investigate the hypothesis using gabapentin as test product.
      Therefore, the first objective of this study is to investigate the individual bioequivalence
      - or switchability - of Gabasandoz® 800 mg relative to Neurontin 800 mg®. The second
      objective is to investigate the individual bioequivalence between two different batches of
      the same medicine, for Gabasandoz® 800 mg and Neurontin® 800 mg.

      This is a two-parted study. The first part is a 6 way crossover pilot study with 12 healthy
      volunteers (men and women). Data from this pilot study will be used to determine the
      following pharmacokinetic parameters: AUC0-t, AUC, Cmax and T1/2. The obtained data will be
      used to develop a Limited Sampling Strategy (LSS), i.e. a strategy to determine AUC and Cmax
      from a limited number of plasma concentrations. A simulation study will be performed, using
      data from the pilot study to determine the amount of volunteers needed to result into an
      appropriate statistical power. This simulation study will be performed according to the FDA
      Guidance for Industry: Statistical Approaches to Establishing Bioequivalence2.

      Part two of the study will be a 6 way crossover and AUC and Cmax will be determined using the
      developed Limited Sampled Strategy.
    

Intervention name(s): Neurontin® (gabapentin) batch A; Neurontin® (gabapentin) batch B; Gabasandoz® (gabapentin) batch A; Gabasandoz® (gabapentin) batch B
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Neurontin® 800 mg tablets (gabapentin) batch A, given 2 times; Neurontin® 800 mg tablets (gabapentin) batch B, given 1 time; Gabasandoz® 800 mg tablets (gabapentin) batch A, given 2 times; Gabasandoz® 800 mg tablets (gabapentin) batch A, given 1 time
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment