OBJECTIVE: The objective was to compare the
bioavailability and
bioequivalence of four generic marketing formulations. METHODS: The study design was a single dose, randomized fou way crossover with a 1 week washout period between each phase of the experiment dosing. Plasma concentration time profiles were determined and the bioavailabilities of different
formulations of nimodipine tablets (A,B, C and D )following oral administration of a 120mg nimodipine single dose were compared.RESULTS:The t max of the tablet A, B, C and D was (0.6 ± 0.2) , (1.1 ± 1.2), (0.5 ± 0.1) and (0.5 ± 0.2) h, respectively; the c max was (108.8 ± 59.5), (56.1 ± 30.7), (73.2±34.9) and (94.7 ± 41.1) ng·ml -1 , respectively; and the
AUC was (175.4 ± 77.9) , (135.8 ±62.4 ), (154.8 ± 69.5) and (154.5 ± 51.6)ng·h·ml -1 , respectively. The relative bioavailabilities of tablet B, C and D compared with tablet A were 83.7%, 93.1% and 97.6%, respectively. The 90% confidence interval for the AUC shown for tablet B and C were 66.7～88.8% and 77.2～102.7%, respectively, less than 80% compared to the reference at the low range estimate; tablet D was 80.5～107.1%, greater than 80% compared to the reference at the low range estimate. CONCLUSION: The 90% confidence interval with respect to AUC was between 80% and 125%, the
formulation B and C were not considered bioequivalent, formulation D was considerded bioequivalent,compared with formulation A.
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