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Studies on bioequivalence of two nimodipine capsules in healthy volunteers

Zou Jian

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Abstract

[Objective]To evaluate the bioequivalence of two domestic Flunarizine capsules. A single oral administration of 20 mg Flunarizine capsule was given to 20 healthy volunteers. Flunarizine concentrations in plasma were determined by HPLC-MS. The main pharmacokinetic parameters of two domestic Flunarizine capsules were as follow: t1/2 (2.43±0.56), (2.38±0.43) h, tmax(2.67±0.82), (2.74±0.80) h, cmax (63.37±15.36), (64.07±14.43) ng/mL,AUC (130.36±15.20), (128.47±20.87) ng/(h·mL) respectively. The relative bioavailability of the test capsule was (101.5±6.3)%. [Conclusion] The results demonstrate that the two capsules are bioequivalent.

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What this paper is about

[Objective]To evaluate the bioequivalence of two domestic Flunarizine capsules. A single oral administration of 20 mg Flunarizine capsule was given to 20 healthy volunteers. Flunarizine concentrations in plasma were determined by HPLC-MS. The main pharmacokinetic parameters of two domestic Flunarizine capsules were as follow: t1/2 (2.43±0.56), (2.38±0.43) h, tmax(2.67±0.82), (2.74±0.80) h, cmax (63.37±15.36), (64.07±14.43) ng/mL,AUC (130.36±15.20), (128.47±20.87) ng/(h·mL) respectively. The relative bioavailability of the test capsule was (101.5±6.3)%. [Conclusion] The results demonstrate that the two capsules are bioequivalent.

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Available abstract

[Objective]To evaluate the bioequivalence of two domestic Flunarizine capsules. A single oral administration of 20 mg Flunarizine capsule was given to 20 healthy volunteers. Flunarizine concentrations in plasma were determined by HPLC-MS. The main pharmacokinetic parameters of two domestic Flunarizine capsules were as follow: t1/2 (2.43±0.56), (2.38±0.43) h, tmax(2.67±0.82), (2.74±0.80) h, cmax (63.37±15.36), (64.07±14.43) ng/mL,AUC (130.36±15.20), (128.47±20.87) ng/(h·mL) respectively. The relative bioavailability of the test capsule was (101.5±6.3)%. [Conclusion] The results demonstrate that the two capsules are bioequivalent.

Key concepts: Bioequivalence, Flunarizine, Bioavailability, Cmax, Capsule, Pharmacokinetics, Pharmacology, Medicine

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