Title: Pharmacokinetics and relative bioavailability of sertraline hydrochloride capsules in healthy volunteers
Abstract: OBJECTIVE To study the relative bioavailability and bioequivalence of Sertraline Hydrochloride capsules and tablets in healthy volunteers.METHODS A single oral dose of 100 mg capsules and tablets was given to 18 healthy volunteers in a randomized crossover study. The concentrations of Sertraline in plasma were determined by HPLC. The pharmacokinetic parameters were calculated and the bioavailabilily and bioequivalence of two formulations were evaluated by 3P97 program. RESULTS After a single dose, the pharmacokinetic parameters for Sertraline capsules and reference formulation were as follows:ρmax(42.1±8.4) and (41.2±6.5)μg·L-1;tmax(5.1±1.0) and (4.6±1.0) h; AUC0-120(1 549.6±315.0) and (1 474.0±299.6) μg·h·L-1; AUC0-inf(1 710.0±322.6) and (1 639.6±314.5)μg·h·L-1, respectively. The 90 % confidential interval of ρmax of capsule was 95.6 %-107.5 % , The 90 % confidential interval of AUC0-120 and AUC0-inf of capsule were 96.2%-114.6% and 96.4%-112.9% , respectively.CONCLUSION The relative bioavailability of capsules and tablets is (107.2±22.5)%; The results of the statistic analysis show that the test and reference formulations are bioequivalence.
Publication Year: 2005
Publication Date: 2005-01-01
Language: en
Type: article
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