Evidence map›Paper›PMID 32196954›Full record

Trial reportClinical pharmacology in drug development2020

Levocetirizine Oral Disintegrating Tablet: A Randomized Open-Label Crossover Bioequivalence Study in Healthy Japanese Volunteers.

Hiroko Ino, Masanari Shiramoto, Takashi Eto, Miwa Haranaka, Shin Irie, Takumi Terao, Hirofumi Ogura, Akira Wakamatsu, Keiko Hoyano, Atsushi Nakano

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacology in drug development, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Green synthesis ofRSC advances · 2026
    Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Hiroko InoClinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.
Masanari ShiramotoSouseikai Hakata Clinic, Fukuoka, Japan.
Takashi EtoSouseikai Hakata Clinic, Fukuoka, Japan.
Miwa HaranakaSouseikai Hakata Clinic, Fukuoka, Japan.
Shin IrieSouseikai Hakata Clinic, Fukuoka, Japan.
Takumi TeraoBiomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.
Hirofumi OguraClinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.
Akira WakamatsuPre-Clinical Development Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.
Keiko HoyanoBiomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.
Atsushi NakanoImmuno-Inflammation Therapeutic Office, Medicines Development, Japan Development, GlaxoSmithKline KK, Tokyo, Japan.
GlaxoSmithKline (Japan) · JPSOUSEIKAI Global Clinical Research Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Administration, OralAdultCetirizineChronic UrticariaCross-Over StudiesDrug CompoundingHealthy VolunteersHistamine H1 Antagonists, Non-SedatingHumansJapanMaleMiddle AgedRhinitis, AllergicSafetyTherapeutic EquivalencyCetirizineHistamine H1 Antagonists, Non-Sedatinglevocetirizinebioequivalencecetirizinehealthy Japanese male subjectsLevocetirizineoral disintegrating tabletsingle dose

Identifiers

PMID32196954
PMCPMC7586835
OpenAlexW3010719633

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.