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  • Title: [Bioequivalence of bambuteral and its metabolites terbutaline after oral bambuteral tablet in healthy volunteers by HPLC/MS].
    Author: Sun CH, Liu L, Yin Q.
    Journal: Yao Xue Xue Bao; 2001 May; 36(5):368-72. PubMed ID: 12584861.
    Abstract:
    AIM: To study bioequivalence of bambuteral and its metablites terbutaline in 20 healthy male volunteers. METHODS: A single oral dose of domestic or imported bambuteral tablet was given according to a randomized 2-way cross-over design. The plasma bambuteral and terbutaline concentrations were determined by HPLC/MS. RESULTS: The pharmacokinetic parameters of domestic and imported bambuteral: AUC0-t were (52 +/- 21) microgram.h.L-1 and (51 +/- 20) microgram.h.L-1, Tmax were (2.9 +/- 0.9) h and (2.6 +/- 0.7) h, Cmax were (6.0 +/- 2.6) microgram.L-1 and (6.2 +/- 2.9) microgram.L-1, T1/2Ke were (11.2 +/- 2.3) h and (11.2 +/- 1.9) h, respectively; terbutaline: AUC0-t were (191 +/- 30) microgram.h.L-1 and (197 +/- 37) microgram.h.L-1; Tmax were (4.2 +/- 1.0) h and (4.2 +/- 1.0) h; Cmax were (10 +/- 5) microgram.L-1 and (10 +/- 4) microgram.L-1; T1/2Ke were (20 +/- 3) h and (21 +/- 4) h, respectively. The bioavaiability of the domestics was 102% +/- 8% (bambuteral) and 100% +/- 12% (terbutaline). CONCLUSION: The results demonstrate that the two forms of bambuteral and terbutaline were bioequivalent by analysis of variance, two-one sided test and 90% confidential limit.
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