The relative bioavailability of clomipramine was determined in two single-blind, singledose, randomized, crossover studies. In the first study, the relative bioavailability of the test product, 2 x 25mg clomipramine hydrochloride tablets (Noristan Ltd.), with respect to the reference product, Anafra
The relative bioavailability of a commercial propranolol hydrochloride tablet in man
โ Scribed by R. Roscoe; J. Cooper; T. W. Wilson; N. N. Joshi; K. K. Midha
- Publisher
- John Wiley and Sons
- Year
- 1982
- Tongue
- English
- Weight
- 412 KB
- Volume
- 3
- Category
- Article
- ISSN
- 0142-2782
No coin nor oath required. For personal study only.
โฆ Synopsis
Abstract
A relative bioavailability study of a conventional tablet of propranolol hydrochloride was conducted in a group of 18 healthy volunteers employing the innovator's product as the reference tablet formulation. Based on plasma levels of propranolol for the 24 h following administration of 2 ยฑ 40 mg oral propranolol hydrochloride tablets, the relative extent of bioavailability was shown to be 100.8 per cent for the test tablet formulation; no significant differences were detected between formulations with respect to any of the pharmacokinetic parameters examined. Large intersubject variations in plasma propranolol concentrations and the subsequently calculated areas under the plasma concentration/time curves were attributed to substantial presystemic biotransformation differences.
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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
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