Comparative bioavailability study of two salbutamol tablets in healthy adult volunteers

Int J Clin Pharmacol Ther. 2009 Jun;47(6):413-8. doi: 10.5414/cpp47413.


This study was carried out to compare the rate and extent of absorption of a generic salbutamol in oral dosage form (Brethmol, 4 mg) with the proprietary equivalent product (Ventolin, 4 mg), in healthy adult subjects, under fasting conditions. The study was a single dose, randomized, two way crossover study with a four-week washout period. It involved 22 healthy volunteers who received a single dose (4 mg) of the test and the reference products after an overnight fast of at least 10 hours. Blood samples were collected at pre-dose and a serial of 14 samples were collected from each of the subject from 1 h until 48 h post-dose. Plasma concentrations of salbutamol were analyzed using GCMS method. The mean AUC(0-yen) values were 91.26 and 96.45 for reference and test product, respectively. The mean C(max) values were 12.26 and 12.38 ng/ml and the mean t(max) values were 2.80 and 2.33 hours for reference and test product, respectively. Analysis of variance showed that the 90% confidence intervals on the relative difference of the ratio for the AUC(0-yen) and the C(max) for the test and reference products were contained within the bioequivalence limit (80 - 125%) (C(max): 89.8 - 110.5% and AUC(0-yen): 91.6 - 121.5%). There was no statistically significant difference for the t(max) between the test and reference formulations (p = 0.30). The test formulation was found to be bioequivalent to the reference formulation with regard to AUC(0-yen) and C(max). There was no statistically significant difference in Brethmol and Ventolin t(max). In conclusion, Brethmol and Ventolin are bioequivalent in healthy subjects.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adrenergic beta-Agonists / administration & dosage
  • Adrenergic beta-Agonists / blood
  • Adrenergic beta-Agonists / pharmacokinetics*
  • Adult
  • Albuterol / administration & dosage
  • Albuterol / blood
  • Albuterol / pharmacokinetics*
  • Biological Availability
  • Cross-Over Studies
  • Drugs, Generic / pharmacokinetics*
  • Female
  • Humans
  • Male
  • Tablets


  • Adrenergic beta-Agonists
  • Drugs, Generic
  • Tablets
  • Albuterol