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Bioequivalence of domestic nimodipine capsules and toblets

Yan Li

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Abstract

Aim The bioequivalence of domestic nimodipine capsules and tablets in healthy volunteers was compared. Methods A single oral dose of capsule or tablet of 100 mg nimodipine was given to 18 healthy volunteers in a randomized crossover study. Plasma levels of the drue were determined with HPLC method. Results The plasma concentration-time curve fitted to the first order absorption, 1- compartment open model. Their main pharmacoknietic parameters were Cmax (56.4±16.9) μg·L-1, t1/2(ke)(2.08±0.42) h, tpeak(1.27±0.52) h,AUC0～9 (197.2 ±46.5) μg·h-1·L-1. These was no statistically significant difference between the two products (P0.05). The relative bioavailability of tested capsules to reference tablets was (99.3±13.1)% Conclusion Both formulations are of bioequivalence.

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What this paper is about

Aim The bioequivalence of domestic nimodipine capsules and tablets in healthy volunteers was compared. Methods A single oral dose of capsule or tablet of 100 mg nimodipine was given to 18 healthy volunteers in a randomized crossover study. Plasma levels of the drue were determined with HPLC method. Results The plasma concentration-time curve fitted to the first order absorption, 1- compartment open model. Their main pharmacoknietic parameters were Cmax (56.4±16.9) μg·L-1, t1/2(ke)(2.08±0.42) h, tpeak(1.27±0.52) h,AUC0～9 (197.2 ±46.5) μg·h-1·L-1. These was no statistically significant difference between the two products (P0.05). The relative bioavailability of tested capsules to reference tablets was (99.3±13.1)% Conclusion Both formulations are of bioequivalence.

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Available abstract

Aim The bioequivalence of domestic nimodipine capsules and tablets in healthy volunteers was compared. Methods A single oral dose of capsule or tablet of 100 mg nimodipine was given to 18 healthy volunteers in a randomized crossover study. Plasma levels of the drue were determined with HPLC method. Results The plasma concentration-time curve fitted to the first order absorption, 1- compartment open model. Their main pharmacoknietic parameters were Cmax (56.4±16.9) μg·L-1, t1/2(ke)(2.08±0.42) h, tpeak(1.27±0.52) h,AUC0～9 (197.2 ±46.5) μg·h-1·L-1. These was no statistically significant difference between the two products (P0.05). The relative bioavailability of tested capsules to reference tablets was (99.3±13.1)% Conclusion Both formulations are of bioequivalence.

Key concepts: Bioequivalence, Nimodipine, Bioavailability, Cmax, Capsule, Crossover study, Pharmacokinetics, Pharmacology

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