| Title | Bioequivalence of two formulations of gabapentin 400 mg capsules: single-dose, open-label, randomized, two-period crossover comparison in healthy Pakistani adult subjects | |
| Authors | Mateen Abba1, Awais Shaukat1, Muhammad Nawaz2, Rakhshanda Nawaz1, Tahira Iqbal1 and Muhammad Saeed2
1. Department of Chemistry, University of Agriculture and 2. Center for Clinical Studies on Drugs, Independent Medical College, Jinnah Colony, Punjab Medical College, Faisalabad 38040, Pakistan |
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| Citation | Abbas, M., Shaukat, A., Nawaz, M., Rakhshanda, N. et al.: Bioequivalence of two formulations of gabapentin 400 mg capsules: single-dose, open-label, randomized, two-period crossover comparison in healthy Pakistani adult subjects, Epitheorese Klin. Farmakol. Farmakokinet. 24(2): 116-119 (2010) | |
| Publication Date | 2010 | |
| Full Text Language | English | |
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| Keywords | Gabapentin, capsules, bioequivalence, pharmacokinetics, HPLC. | |
| Other Terms | Review article | |
| Summary | A randomized, two-way, crossover, bioequivalence study was conducted in 20 fasting, healthy, male volunteers to compare two brands of Gabapentin 400 mg capsules, NEOGAB® (manufactured by Hilton Pharma (Pvt) Limited, Progressive Plaza, Beaumont Road, Karachi, Pakistan) as a test and NEURONTIN® (manufactured by Godecke AG/ Germany under license of Parke-Davis) as a reference product. One capsule of either formulation was administered with low-carbonate water after 10 h of overnight fasting. After dosing, serial blood samples were collected during a period of 48 hours. Plasma samples were analysed for Gabapentin by a validated HPLC method. The pharmacokinetic parameters AUC0-24, AUC0-α, Cmax, Tmax, Kel, T1/2, and CL were determined from plasma concentration-time profiles for both formulations and were compared statistically to evaluate bioequivalence between the two brands of Gabapentin, using the statistical modules re-commended by FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals (CI) fell within the acceptable range for bioequivalence. Based on these statistical inferences it was concluded that the two brands exhibited comparable pharmacokinetics profiles. | |
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Online ISSN 1011-6575
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Articles published in this Journal are Indexed or Abstracted in: • Chemical Abstracts • Elsevier’s Bibliographic Databases: Scopus, EMBASE, EMBiology, Elsevier BIOBASE SCImago Journal and Country Rank Factor
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