Related Experiment Video
Updated: Dec 25, 2025

Formation of Dispersible Taohong Siwu Tablets
Published on: February 3, 2023
Levocetirizine Oral Disintegrating Tablet: A Randomized Open-Label Crossover Bioequivalence Study in Healthy Japanese
Hiroko Ino1, Masanari Shiramoto2, Takashi Eto2
1Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.
Abstract:
Levocetirizine is classified as a second-generation antihistamine. Levocetirizine is available for the treatment of allergic disorders such as allergic rhinitis and chronic idiopathic urticaria. This was a single-center, single-dose, open-label, randomized, 2-way crossover study in healthy Japanese male subjects consisting of 2 parts. Part 1 compared the bioavailability of levocetirizine oral disintegrating tablet (ODT) and levocetirizine immediate-release tablet (IRT) taken with water in the fasted state in 24 subjects; all subjects completed this part of the trial. In part 2, the bioavailability of levocetirizine ODT without water was compared with that of levocetirizine IRT with water in the fasted state in 48 subjects; 47 subjects completed this part of the trial. Bioequivalence was demonstrated between levocetirizine IRT 5 mg and ODT 5 mg. The safety profiles were generally similar between levocetirizine ODT and levocetirizine IRT, with no serious adverse events, deaths, or adverse events leading to withdrawal reported during the study.
More Related Videos
04:28Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals
Published on: March 23, 2016
09:16Author Spotlight: Optimization of Processing Technology for Tiebangchui with Zanba Based on CRITIC Combined with Box-Behnken Response Surface Method
Published on: May 12, 2023
Related Concept Videos
Bioavailability Study Design: Healthy Subjects Versus Patients
Bioequivalence studies: Biowaivers
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
Bioequivalence: Overview
Bioavailability Study Design: Single Versus Multiple Dose Studies
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence