Bioequivalence assessment of meloxicam granules in Chinese healthy volunteers
Wang Jiu-hui
Abstract
Wang Jiu-hui
Abstract
Aim To evaluate the bioequivalence of meloxicam granules in healthy volunteers.Methods The randomized crossover and self-control study was conducted in 20 healthy volunteers.They were treated with a single oral dose of 15mg of meloxicam granules or a single oral dose of control drug(meloxicam tablets).The meloxicam concentrations in plasma were detected by RP-HPLC.Results The mean Tmax was(3.3±1.6)h for meloxicam granules and(4.7±1.1) h for meloxicam tablets;the mean Cmax was(0.652±0.109)and(0.532±0.106)μg/mL respectively;T1/2 was(26.56±11.29) and(26.87±9.99)h respectively;AUCO 96 was(20.083±6.182)and(l8.767±6.165)μg·h/mL respectively;AUC0∞was (23.901±8.624)and(22.452±7.548)μg·h/mL respectively;The relative bioavailability of meloxicam granules was(113.8±35.5)%.Conclusion The meloxicam orally suspension is bioequivalent to the meloxicam tablets.
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Aim To evaluate the bioequivalence of meloxicam granules in healthy volunteers.Methods The randomized crossover and self-control study was conducted in 20 healthy volunteers.They were treated with a single oral dose of 15mg of meloxicam granules or a single oral dose of control drug(meloxicam tablets).The meloxicam concentrations in plasma were detected by RP-HPLC.Results The mean Tmax was(3.3±1.6)h for meloxicam granules and(4.7±1.1) h for meloxicam tablets;the mean Cmax was(0.652±0.109)and(0.532±0.106)μg/mL respectively;T1/2 was(26.56±11.29) and(26.87±9.99)h respectively;AUCO 96 was(20.083±6.182)and(l8.767±6.165)μg·h/mL respectively;AUC0∞was (23.901±8.624)and(22.452±7.548)μg·h/mL respectively;The relative bioavailability of meloxicam granules was(113.8±35.5)%.Conclusion The meloxicam orally suspension is bioequivalent to the meloxicam tablets.
Key concepts: Meloxicam, Bioequivalence, Bioavailability, Cmax, Crossover study, Medicine, Pharmacology, Plasma concentration