Bioequivalence of quinidine in two sustained-release preparations

M. Garty*, A. Rachmel, D. Ilfeld, Y. Sinai, R. Paz

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


The bioequivalence of two sustained-release preparations of quinidine bisulphate from Teva (Israel) and from Astra (Sweden) was assessed in an acute, single-dose randomized cross-over study in seven healthy subjects. There was no significant difference in time to peak, peak serum concentration, area under the concentration time curve from 0 to ∞, and the fraction absorbed between quinidine bisulphate 500 mg from Teva and from Astra. In addition, quinidine bisulphate 250 mg from Teva was compared with the short-acting quinidine sulphate 200 mg. The quinidine bisulphate from Teva had a significantly (P < 0.025) decreased peak serum concentration and an increased time to peak compared with the short-acting ∞, quinidine sulphate, although these two drugs are similar for the area under the curve from 0 to ∞. Our pharmaceutical records show that 85% of outpatients receiving quinidine are given the sustained-release quinidine bisulphate. However, only 36% of the outpatients prescribed sustained-release quinidine bisulphate are appropriately prescribed for twice-daily treatment. Thus the quinidine bisulphate from Teva is a sustained-release preparation with bioequivalence to the reference sustained-release preparation and can be administered twice daily.

Original languageEnglish
Pages (from-to)357-361
Number of pages5
JournalIsrael Journal of Medical Sciences
Issue number6
StatePublished - 1992
Externally publishedYes


  • Bioavailability
  • Quinidine
  • Slow-release preparation


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