Bioequivalence of rupatadine furmarate capsule and tablet in healthy volunteers

Abstract

Abstract: AIM: To evaluate the bioequivalence of furmarate rupatadine capsule and tablet(reference drug). METHODS: 10 mg test preparation and reference preparation were given to 20 male healthy volunteers in two-way crossover design for the pharmacokinetic and relative bioavailability study. Plasma concentrations of rupatadine were detected by LC-ESI-MS/MS. RESULTS: The pharmacokinetic parameters of the reference and test preparations were as the followings: C_max(10.2±5.4) and (10.4±4.9) μg/L, t_max(0.79±0.36) and (0.66±0.17) h, AUC_0-24(28±15) and (27±17) μg·L^-1·h, AUC_0-∞(30±17) and (28±19) μg·L^-1·h, t_1/2(7.0±4.4) and (5.6±3.4) h, respectively. The mean relative bioavailability of the test prparation vs reference prparation was (99±23)%. CONCLUSION: The furmarate rupatadine capsule and tablet are bioequivalent.

Key words: Rupatadine, LC-ESI-MS/MS, Pharmacokinetics, Bioequivalence

CLC Number:

R969

ZHANG Ji-rong, YAO Kai, FU Zhi-min, TAN Hong-yi, TAN Zhi-rong, HUANG Zhi-jun. Bioequivalence of rupatadine furmarate capsule and tablet in healthy volunteers[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2010, 15(5): 519-523.

References

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