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KMID : 0369820050350030193
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Jorunal of Korean Pharmaceutical Sciences
2005 Volume.35 No. 3 p.193 ~ p.199
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Bioequivalence of Kuhnil Gabapentin(TM) Capsule 300mg to Neurontin(TM) Capsule 300mg (Gabapentin 300mg)
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조혜영/Cho HY
강현아/박은자/오세원/문재동/이용복/Kang HA/Park EJ/Oh SW/Moon JD/Lee YB
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Abstract
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Gabapentin is an antiepileptic drug that is structurally similar to γ?aminobutyric acid (GABA), but does not interact with the GABA receptor. It does not bind significantly to plasma proteins, and is excreted to unchanged form in the urine. The purpose of the present study was to evaluate the bioequivalence of two gabapentin capsules, NeurontinTM capsule 300 mg (Pfizer Pharm. Co., Ltd.) and Kuhnil GabapentinTM capsule 300 mg (Kuhnil 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 various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, 22.46±1.86 years in age and 67.64±7.24 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After a single capsule containing 300 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 at all dissolution media. In addition, 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, NeurontinTM capsule 300 mg, were -2.03, -0.43 and 4.29% 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.,log0.89∼log1.09andlog0.91∼log1.09 for AUCt and Cmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil GabapentinTM capsule 300 mg was bioequivalent to NeurontinTM capsule 300 mg.
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KEYWORD
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Gabapentin, Neurontin, Kuhnil Gabapentin, Bioequivalence, HPLC
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