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KMID : 0370220080520040299
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Yakhak Hoeji
2008 Volume.52 No. 4 p.299 ~ p.305
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Bioequivalence Test of Gabapentin 800 mg Tablets
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Kim Se-Mi
Shin Sae-Byeok
Kang Hyun-Ah
Cho Hea-Young
Lee Yong-Bok
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Abstract
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Gabapentin, 1-(aminomethyl) cyclohexaneacetic acid, is a amino acid derivative, and is clinically effective in the treatment of neuropathic pain and partial seizures of epilepsy as a complementary therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin tablets, Neurontin® tablet 800 mg (Pfizer Pharmaceuticals Co., Ltd.) and Gabapenin tablet 800 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with 0.06 M HCl dissolution media. Twenty six healthy male subjects, 23.85±2.24 years in age and 69.40±11.11 kg in body weight, were divided into two groups and a randomized 2×2 crossover study was employed. After a single tablet containing 800 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution media. The pharmacokinetic parameters such as AUCt, Cmax and Tmax were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt, Cmax and untransformed Tmax. The results showed that the differences between two formulations based on the reference drug, Neurontin®, were 1.28%, 0.63% and 0.62% for AUCt, Cmax and Tmax, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log0.9097~log1.1598 and log0.8919~log1.1262 for AUCt and Cmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabapenin tablet 800 mg was bioequivalent to Neurontin® tablet 800 mg.
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KEYWORD
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Gabapentin, Neurontin® tablet, Gabapenin tablet, Bioequivalence, HPLC
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