Pharmacokinetics and Bioequivalence of Venlafaxine Hydrochloride Capsules in Healthy Volunteers
Zhang Quan-ying
Abstract
Zhang Quan-ying
Abstract
A LC-MS/MS method was established for the determination of venlafaxine in human plasma. According to a randomized two-period crossover design,the pharmacokinetics and bioequivalence after single dose oral administration of test and reference capsules in 24 healthy volunteers were investigated. The pharmacokinetic parameters of test and reference capsules were as follows:cmax (71.1±29.9) and (71.2±26.6) ng/ml,tmax (2.31±0.67) and (2.31± 0.75) h,t1/2 (4.68±1.30) and (4.83±1.39) h,AUC0→24 (534.7±334.6) and (543.9± 370.3) h·ng·ml-1,respectively. The relative bioavailability of the preparation was (101.8±18.3)%. The two formulations are bioequivalent.
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A LC-MS/MS method was established for the determination of venlafaxine in human plasma. According to a randomized two-period crossover design,the pharmacokinetics and bioequivalence after single dose oral administration of test and reference capsules in 24 healthy volunteers were investigated. The pharmacokinetic parameters of test and reference capsules were as follows:cmax (71.1±29.9) and (71.2±26.6) ng/ml,tmax (2.31±0.67) and (2.31± 0.75) h,t1/2 (4.68±1.30) and (4.83±1.39) h,AUC0→24 (534.7±334.6) and (543.9± 370.3) h·ng·ml-1,respectively. The relative bioavailability of the preparation was (101.8±18.3)%. The two formulations are bioequivalent.
Key concepts: Bioequivalence, Pharmacokinetics, Cmax, Bioavailability, Chemistry, Venlafaxine Hydrochloride, Crossover study, Pharmacology