Pharmacokinetics and bioequivalence evaluation of two gabapentin preparations after a single oral dose in healthy Korean volunteers
H.Y. Cho, H.A. Kang, Y.B. Lee
1 College of Pharmacy and Institute of Bioequivalence and Hospital Bridging Study, 2 Clinical Trial Center, CNUH, Chonnam National University, Gwangju, Korea
DOI 10.5414/CPP44386
Abstract
Objective: To evaluate the bioequivalence of a single oral 400 mg dose of 2 gabapentin preparations in healthy male Korean volunteers. Subjects, materials and methods: The study was conducted as a randomized, 2-period crossover design in 26 healthy male Korean volunteers who received a single oral dose of 400 mg gabapentin capsule in each study period. There was a 7-day washout period between the doses. Serum concentrations of gabapentin up to 24 hours after the administration were determined using a validated HPLC method with fluorescence detection. In addition, in vitro dissolution profiles of both preparations were examined. The pharmacokinetic parameters such as AUC0-t (the area under the curve from zero to the time), AUC0-¥ (the area under the curve from zero to infinity), Cmax (maximum serum concentration), tmax (time to reach Cmax) and t1/2 (terminal half-life) were analyzed by non-compartmental analysis, and the analysis of variance (ANOVA) was carried out using logarithmically transformed AUC0-t, AUC0-¥ and Cmax and untransformed tmax. Results: In vitro dissolution profiles were very similar at all media. There were no significant differences between the two preparations in AUC0-t, AUC0-¥ and Cmax. The point estimates (90% confidence intervals) for AUC0-t, AUC0-¥ and Cmax were 1.0319 (0.9142 – 1.1647), 1.0127 (0.8458 – 1.2127) and 0.9796 (0.8670 – 1.1069), respectively, satisfying the bioequivalence criteria of 0.80 – 1.25 as proposed by the US FDA and the Korean legislation. No statistically significant difference was found for tmax and t1/2 values. Conclusion: From the results of the present study, it is indicated that the two preparations of gabapentin are bioequivalent and it can be assumed that they are therapeutically equivalent and exchangeable in clinical practice.
Author Details
Authors
Departments
- 1 College of Pharmacy and Institute of Bioequivalence and Hospital Bridging Study,
- 2 Clinical Trial Center, CNUH, Chonnam National University, Gwangju, Korea
Address
Dr. Y.B. Lee
College of Pharmacy and Institute of Bioequivalence and Bridging Study
Chonnam National University
300 Yongbong-Dong, Buk-Gu, Gwangju 500-757, Korea
Email:
[email protected]
Citation
H.Y. Cho, H.A. Kang and Y.B. Lee.Pharmacokinetics and bioequivalence evaluation of two gabapentin preparations after a single oral dose in healthy Korean volunteers. 2006; 44: 386-392. doi: 10.5414/CPP44386.
