Comparison of tadalafil pharmacokinetics after administration of a new orodispersible film versus a film-coated tablet.

ABSTRACT:

Background

An orodispersible film (ODF) of tadalafil may provide increased convenience for erectile dysfunction (ED) patients as compared to conventional tablet formulations. In this study, we aimed to compare the pharmacokinetic, safety, and tolerability profiles of a newly developed ODF formulation of tadalafil to those of a film-coated tablet (FCT) of tadalafil.

Materials and methods

This study was conducted in healthy male subjects using an open-label, randomized sequence, two-period, two-formulation, single-dose, crossover design. The subjects were randomly assigned to one of two sequences of the two formulations: both the test drug (ODF) and the reference drug (FCT) contained 20 mg of tadalafil. Blood samples were collected up to 72 h after administration. Plasma conce

SUBMITTER: Park SI 

PROVIDER: S-EPMC5916261 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature