Title: Bioequivalence of Fluoxetine Hydrochloride Orally Disintegrating Tablets in Healthy Volunteers
Abstract: OBJECTIVE:To study the pharmacokinetics and the relative bioavailability of fluoxetine hydrochloride orally disintegrating tablets in healthy volunteers.METHODS:A single oral dose of 40 mg fluoxetine hydrochloride orally integrating tablets(test preparation) and 40 mg fluoxetine hydrochloride capsules(reference) were given to 18 healthy volunteers by a randomized crossover way.The concentrations of fluoxetine hydrochloride in plasma were determined by HPLC;the pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and bioequivalence was evaluated.RESULTS:The time-concentration curves of test and reference preparations of fluoxetine hydrochloride fitted two compartment model with the main pharmacokinetic parameters stated as follows:tmax were(5.17±1.10) h and(5.11±1.02) h;Cmax were(76.24±38.42) ng·mL-1 and(77.92±34.97) ng·mL-1;AUC0~150 were(3 216.21±899.69) ng·h·mL-1 and(3 220.62±1 275.57) ng·h·mL-1,and AUC0~∞ were(3 570.60±1 299.29) ng·h·mL-1 and(3 662.49±1 444.69) ng·h·mL-1,respectively.The t test results showed that the two preparations had no significant difference in pharmacokinetic parameters(P0.05).The relative bioavailability of the test preparation was(96.47±10.43)%.CONCLUSION:The result demonstrated that the two formulations were bioequivalent.
Publication Year: 2008
Publication Date: 2008-01-01
Language: en
Type: article
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