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  • Title: [Pharmacokinetics and relative bioavailability of KC-404 sustained release tablets in healthy volunteers].
    Author: Li T, Pang Y, Wang Z, Jia Y, Cheng Q, Sun J.
    Journal: Sichuan Da Xue Xue Bao Yi Xue Ban; 2003 Jul; 34(3):541-3. PubMed ID: 12910715.
    Abstract:
    OBJECTIVE: To study the pharmacokinetics and relative bioavailability of KC-404 sustained release tablets and capsules in healthy volunteers. METHODS: The concentration of KC-404 in serum was determined by HPLC method after a single oral dose (20 mg) of tablet or capsule was administered to 19 healthy male volunteers respectively in an open randomized cross-over test. RESULTS: After being processed by 3P87 pharmacokinetics program, the experiment data showed that the pharmacokinetic parameters of the tablets and the capsules were AUC0-->infinity: 740.12 ng.h/ml and 724.04 ng.h/ml; tmax: 5.37 h and 5.11 h; Cmax: 46.98 ng/ml and 46.29 ng/ml; T1/2: 7.4 h and 7.0 h; MRT0-->infinity: 14.78 h and 14.39 h respectively. There were no significant differences in AUC, tmax, Cmax, T1/2 and MRT0-->infinity between these two preparations (P > 0.05). The relative bioavailability of KC-404 sustained release tablets was 102.6%. CONCLUSION: These two preparations are bioequivalent.
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