Study on pharmacokinetics and bioequivalent evaluation of Nimodipine tablet
Xuehua Jiang
Abstract
Xuehua Jiang
Abstract
The pharmacokinetics and relative bioavailability of Nimodipine tablets were studied. Nimodipine was determined after a single oral dose of two Nimodipine preparations were given respectively to 10 volunteers in an open randomized cross - over test. Nimodipine concentration in plasma was assayed by RP - HPLC method. After taking a single oral dose 120mg two Nimodipine preparations, the AUC0→∞ of Nimodipine test preparations and standard preparations were 82.51 ± 28. 73ng/ml × h and 82. 92 ± 30. 93ng/ml × h; Tmax were 1. 75 ±0. 26h and 1. 70 ±0. 26h; Cmax were 28. 84 ±9. 05ng/ml and 29. 05 ± 8. 69ng/ml respectively. The result of statistical analysis showed that there were no significant difference of the AUC0→∞、× Tmax and Cmax of Nimodipine between the two formations and the two Nimodipine tablets were bioequivalent.
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The pharmacokinetics and relative bioavailability of Nimodipine tablets were studied. Nimodipine was determined after a single oral dose of two Nimodipine preparations were given respectively to 10 volunteers in an open randomized cross - over test. Nimodipine concentration in plasma was assayed by RP - HPLC method. After taking a single oral dose 120mg two Nimodipine preparations, the AUC0→∞ of Nimodipine test preparations and standard preparations were 82.51 ± 28. 73ng/ml × h and 82. 92 ± 30. 93ng/ml × h; Tmax were 1. 75 ±0. 26h and 1. 70 ±0. 26h; Cmax were 28. 84 ±9. 05ng/ml and 29. 05 ± 8. 69ng/ml respectively. The result of statistical analysis showed that there were no significant difference of the AUC0→∞、× Tmax and Cmax of Nimodipine between the two formations and the two Nimodipine tablets were bioequivalent.
Key concepts: Nimodipine, Bioequivalence, Cmax, Pharmacokinetics, Bioavailability, Medicine, Pharmacology, Internal medicine