Buy Gabapentin 800 mg

 

The interchangeability of gabapentin 800 mg tablets: a randomized, controlled trial to establish individual bioequivalence

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Background

International Nonproprietary Name (INN) prescribing, i.e. using the INN instead of the brand name for prescribing, and/or generic substitution is allowed in different European countries. For some products it is advised not to switch between medicinal products from different manufacturers once treatment started, because it is believed that they are not completely interchangeable. Therefore, we aimed to investigate (1) the interchangeability of gabapentin 800mg tablets marketed as Neurontin® and Gabasandoz® following FDA guidelines using the individual bioequivalence (IBE) approach and (2) the interchangeability in a more real-life situation by including two different batches of each product (Neurontin® & Gabasandoz®, both Batch ‘A’ and ‘B’).

Materials and Methods

Thirty healthy subjects received 6 times - in randomized order - a single dose of 800 mg Neurontin® (Batch A or B) or 800 mg Gabasandoz® (Batch A or B). Serum concentrations of gabapentin up to 36 hours after dosing were determined. According to FDA guidelines, IBE can be established if the 95% upper-confidence bound (UCB) of η (ie, a function of different variance terms) is lower than the IBE limit θ, which is 2.5. For AUC0-inf and Cmax, η and its 95% UCB were calculated.

Results

For AUC∞ and Cmax η was 0.58 and 0.19, respectively, and the 95% UCB was 1.32 and 0.63 (both P value < 0.001), respectively. When including data on batch ‘B’ of Neurontin® and Gabasandoz®, η was 0.46 and –0.08 for AUC0-inf and Cmax, respectively. The 95% UCB was 1.20 and 0.40, respectively (both P value <0.001). All UCB were below the IBE limit θ, showing IBE.

Conclusion

This study indicates that Neurontin® 800mg (Batch ‘A’) and Gabasandoz® 800 mg (Batch ‘A’) are individually bioequivalent and interchangeable in clinical practice. This interchangeability remains when resembling a more real-life situation by adding an additional batch of each product (Batch ‘B’).