Journal of Bioequivalence & Bioavailability

A single-blind, randomized, two-part, 6-way cross-over study to investigate the individual bioequivalence of gabapentin 800 mg tablets as Neurontin? 800 mg and its generic Gabasandoz? in healthy volunteers

5^th World Congress on Bioavailability and Bioequivalence Pharmaceutical R&D Summit

September 29-October 01, 2014 DoubleTree by Hilton Baltimore-BWI Airport, USA

Elien Van Bever

Posters: J Bioequiv Availab

Abstract:

T he first aim was to investigate switchability of Neurontin? 800 mg (2x Batch ?A?) and Gabasandoz? 800 mg (2x Batch ?A?) using the individual bioequivalence (IBE) approach. The second was to investigate switchability in a more real-life situation by including two different batches of each product (Neurontin? Batch ?B?, Gabasandoz? Batch ?B?). This study was conducted in 30 healthy subjects, of whom 29 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 using a validated UPLC-MS-MS method. According to the FDA, IBE can be established if the 95% upper-confidence bound (UCB) of η (i.e., a function of different variance terms) is lower than the IBE limit θ, which is 2.5. For AUC(0-inf) and Cmax, η and its 95% UCB were calculated. η was 0.58 and 0.19 for AUC(0-inf) and Cmax, 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 AUC(0-inf) and Cmax, respectively. The 95% UCB was 1.20 and 0.40, respectively (both p-value <0.001). This study indicates that Neurontin? 800 mg (Batch ?A?) and Gabasandoz? 800 mg (Batch ?A?) are individual bioequivalent and switchable in clinical practice. When simulating a more real-life situation by expanding the experimental design with an additional batch of each product (Batch ?B?), both brands still met the switchability criteria

Biography :

Elien Van Bever is a pharmacist, clinical pharmacologist-in-training and PhD-student at the Ghent University, Ghent, Belgium. She started her PhD in 2011, which involves topics such as generic prescribing and substitution, individual bio-equivalence and switchability of medicines, and prescribing regulation