Title: Bioavailability of loratadine tablet in healthy subjects
Abstract: Objective: To study the relative bioavailability and pharmacokinetics of loratadine tablet in healthy subjects. Methods: A single oral dose of 20 mg of loratadine tablet made in Chongqing or Shanghai (LORAL or LORAS) was given to 20 healthy volunteers in a randomized crossover study. Drug concentrations in plasma were determined by HPLC. The pharmacokinetics parameter were calculated with 3p97 pharmacokinetic program and the bioequivalency was evaluated. Results: The results showed that the plasma concentration-time curve of the two preparations were all fitted to a one-compartment model. The peak plasma levels (Cmax) of LORAL or LORAS were (13.11±9.15)ng/ml or (12.18±7.04)ng/ml; the peak time (Tmax) were (0.99±0.48)h or (0.95±0.54)h; AUC0-T were (30.21±17.69)ng·h/ml or (30.96±18.27)ng·h/ml, respectively. The relative bioavailability of LORAL was 97.58%. Conclusion: The result of two one-sided tests suggest that the LORAL is bioequivalence with the LORAS.
Publication Year: 2004
Publication Date: 2004-01-01
Language: en
Type: article
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