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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2001  >  (3): 146-148

LIU Xin-yu, WU Fang, CHEN Lian-jian. Evaluation of bioequivalence assessment after single dose theophylline sustained release capsules in healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2001, (3): 146-148.
Citation: LIU Xin-yu, WU Fang, CHEN Lian-jian. Evaluation of bioequivalence assessment after single dose theophylline sustained release capsules in healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2001, (3): 146-148.
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Evaluation of bioequivalence assessment after single dose theophylline sustained release capsules in healthy volunteers

  • Shenzhen Futian Hospital, Guangdong Medical College, Shenzhen 518033, China

  • Received Date: 2001-02-12
  • OBJECTIVE To evaluate the bioequivalence assessment of theophylline sustained release capsules in healthy volunteers.METHODSA reversed phase high performance liquid chromatography (RP-HPLC) method was est ablished for the determination of theophylline in plasma after a single oral dose of 200mg domestic theophyline sustained-release capsules and imported theophylline sustained-release capsules in a randomized crossover design.The detector was operated at UV 273nm.RESULTS The dynamic course of theophylline plasma concent rations conformed to a one-compartment open model with a 3P87 program and the main pharmacokinetic parameters after a single oral dose of 200mg domestic sustained-release capsules and imported sust ained-re-lease capsules were as folows Cmax were(5.12±0.74)mg/L and(5.14±0.63)mg/L,tmax were(5.4±1.0)h and(5.3±1.1)h,MRT were(17.79±1.48)h and(17.61±1.78)h,t1/2 were(10.55±0.75)h and(10.59±1.10)h,AUC0-36 were(85.33±10.56)mg·h/L and(86.26±8.80)mg·h/L,respectively.CONCLUSIONS The relative bioavailability of domestic theophylline sustained-release capsules is(98.9±6.4)%.The results of statistical analysis for Cmax,AUC0-36 and AUC0-∞ showed that domestic sustained-release capsules and imported sustained-release capsules were bioequivalent.
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Evaluation of bioequivalence assessment after single dose theophylline sustained release capsules in healthy volunteers

  • Shenzhen Futian Hospital, Guangdong Medical College, Shenzhen 518033, China
  • Received Date: 2001-02-12

Abstract: OBJECTIVE To evaluate the bioequivalence assessment of theophylline sustained release capsules in healthy volunteers.METHODSA reversed phase high performance liquid chromatography (RP-HPLC) method was est ablished for the determination of theophylline in plasma after a single oral dose of 200mg domestic theophyline sustained-release capsules and imported theophylline sustained-release capsules in a randomized crossover design.The detector was operated at UV 273nm.RESULTS The dynamic course of theophylline plasma concent rations conformed to a one-compartment open model with a 3P87 program and the main pharmacokinetic parameters after a single oral dose of 200mg domestic sustained-release capsules and imported sust ained-re-lease capsules were as folows Cmax were(5.12±0.74)mg/L and(5.14±0.63)mg/L,tmax were(5.4±1.0)h and(5.3±1.1)h,MRT were(17.79±1.48)h and(17.61±1.78)h,t1/2 were(10.55±0.75)h and(10.59±1.10)h,AUC0-36 were(85.33±10.56)mg·h/L and(86.26±8.80)mg·h/L,respectively.CONCLUSIONS The relative bioavailability of domestic theophylline sustained-release capsules is(98.9±6.4)%.The results of statistical analysis for Cmax,AUC0-36 and AUC0-∞ showed that domestic sustained-release capsules and imported sustained-release capsules were bioequivalent.

LIU Xin-yu, WU Fang, CHEN Lian-jian. Evaluation of bioequivalence assessment after single dose theophylline sustained release capsules in healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2001, (3): 146-148.
Citation: LIU Xin-yu, WU Fang, CHEN Lian-jian. Evaluation of bioequivalence assessment after single dose theophylline sustained release capsules in healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2001, (3): 146-148.
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