Pharmacokinetics of oral pridinol: Results of a randomized, crossover bioequivalence trial in healthy subjects.

ABSTRACT:

Objectives

To establish the relative bioavailability and to assess bioequivalence of oral, immediate-release tablets containing pridinol and to determine the pharmacokinetic properties of the compound.

Methods and materials

In this single-center, open-label, randomized, crossover trial, healthy male and female adult subjects received single doses of the test and reference product containing 4 mg pridinol mesylate (equivalent to 3 mg pridinol) each under fasting conditions. For pharmacokinetic evaluation, blood samples were withdrawn until 72 hours post dose. Pridinol in plasma was quantified by validated liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS). Adverse events (AEs) were analyzed descriptively.

Results

Of 34 randomized subjects, 33 complete

SUBMITTER: Richter M 

PROVIDER: S-EPMC8167741 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature