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Relative Bioavailability and Bioequivalent of Citalopram Tables in Healthy Volunteers
Author: ZhuGangZhi
Tutor: TangShengSong
School: Nanhua University
Course: Pharmacology
Keywords: Citalopram HPLC The relative bioavailability of Bioequivalence
CLC: R96
Type: Master's thesis
Year: 2007
Downloads: 113
Quote: 0
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Abstract
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Objective To study the West citalopram tablets in healthy male volunteers in vivo bioavailability and bioequivalence . The method in accordance with the guiding principles of GCP , two - period crossover design , 18 healthy male subjects were randomly divided into two groups , were given a single oral dose of test preparation or reference preparations 2 x 20mg time point in the design of venous blood . HPLC method plasma concentration at different times after administration were measured by plasma concentration data for each of the main pharmacokinetic parameters main pharmacokinetic parameters of mean difference test , analysis of variance , with two one-sided t - test was used for the bioequivalence judgment . Citalopram tablets the test preparation and reference preparation main pharmacokinetic the parameters AUC 0 → 144 < / sub > , AUC 0 → ∞ < / sub > , T max < / sub >, C max were 1665.0 ± 318.3 ng · h / ml and 1670.6 ± 346.2 ng · h / ml , 1806.0 ± 371.6 ng · h / ml and 1822.9 ± 404.7 ng · h / ml , 4.6 ± 0.9 h and 4.6 ± 1.4 h, 34.3 ± 3.8 ng / ml and 35.2 ± 4.3 ng / ml . Reference preparation relative bioavailability of the test formulation of 100.5 ± 10.8 % . Statistical analysis indicated that the test formulation and reference no significant difference in the preparation of the main pharmacokinetic parameters between the two one-sided t-test results show that the test formulation and reference formulations are bioequivalent . Conclusion of the test preparation and reference preparation are bioequivalent .
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