OBJECTIVE To study the bioavailability of arbidol hydrochloride capsule, tablet and reference, and evaluate its bioequivalence in healthy volunteers. METHODS A single oral dose of 600 mg arbidol hydrochloride capsule, tablet or reference, was given to 24 healthy male volunteers according to an open randomized 3 way crossover design. Plasma concentration of arbidol was determined by HPLC method. RESULTS The pharmacokinetics parameters of the three products were as follows:tmax (1.74±0.86),(1.60±1.22)and (1.66±1.21)h; ρmax (1 031.24±405.55),(1 101.32±530.17)and (1 143.25±635.86) μg·L-1; AUC0-t (7 653.93±2 880.87),(8 087.31±3 162.71)and (8 126.53±3 911.13) μg·h·L-1, t1/2 (13.10±4.13),(13.00±3.97)and (13.80±4.30)h, respectively. The relative bioequivalence of arbidol hydrochloride capsules and tablets were (99.1±21.5)%,(105.8±39.8)%, respectively.CONCLUSION Three formations were bioequivalence by analysis of variance, two-one side test and 90% confidential interval.
FENG Yu-fei;Lü Jun-ling;SONG Li-jie;LI Ke-xin;SUN Chun-hu.
Pharmacokinetics and Relative Bioavailability of Arbidol Hydrochloride Tablets and Capsules in Chinese Healthy Volunteers [J]. Chinese Pharmaceutical Journal, 2008, 43(16): 1257-1259
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