Bioavailability of propranolol hydrochloride tablet formulations: Application of multiple dose crossover studies
✍ Scribed by Dr. Michael A. Eldon; Arlyn W. Kinkel; Jane E. Daniel; Jeffrey R. Latts
- Publisher
- John Wiley and Sons
- Year
- 1989
- Tongue
- English
- Weight
- 404 KB
- Volume
- 10
- Category
- Article
- ISSN
- 0142-2782
No coin nor oath required. For personal study only.
✦ Synopsis
Two multiple dose crossover pharmacokinetic studies were carried out to determine the steady-state bioavailability of newly formulated generic propranolol HCI tablets relative to lnderalo tablets. In Study I, 24 healthy volunteers were dosed with 4 x lOmg test tablets, 1 x 40 mg test tablet, 4 x 10 mg Inderal tablets, and 40 mg of propranolol HCI in solution. In Study II,24 healthy volunteers were dosed with 1 x 80 mg test tablet, 1 x 80 mg Inderal tablet, and 80mg of propranolol HCI in solution. Both studies were of randomized design with each formulation administered every 8 h for 15 doses. Serial plasma samples were obtained for 8 h after morning doses on Days 4 and 5 of each treatment period and assayed for propranolol using a validated HPLC method. Mean plasma concentration-time data for test tablets and reference tablets were superimposable in both studies.
Pharmacokinetic parameters from Days 4 and 5 were combined for statistical analysis since subjects were determined to have reached steady-state. and Cmi. values were not statistically different between test tablets and Inderal tablets in either study. Based on these findings, the test tablets demonstrated the same rate and extent of propranolol absorption as did corresponding InderaP tablets. Therefore, the test tablets and Inderala tablets were determined to be bioequivalent.