Evidence map›Paper›PMID 27197662›Full record

Trial reportClinical and translational science2016

The Pharmacokinetic Exposure to Fexofenadine is Volume-Dependently Reduced in Healthy Subjects Following Oral Administration With Apple Juice.

J Luo, H Imai, T Ohyama, S Hashimoto, T Hasunuma, Y Inoue, T Kotegawa, K Ohashi, N Uemura

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.5field-weighted citation impact, top 17% 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

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. A Mechanistic Physiologically Based Pharmacokinetic (PBPK) modeling approach for fexofenadine: predictive pharmacokinetic insights in humans.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2025
    Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. How to Conduct Clinical Trials in Children: A Tutorial.Clinical and translational science · 2019
    Article
  8. 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

9 authors at 2 institutions in 1 country.

J LuoDepartment of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University, Japan.
H ImaiDepartment of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University, Japan.
T OhyamaDepartment of Mathematics and Statistics, Faculty of Medicine, Oita University, Japan.
S HashimotoDepartment of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University, Japan.
T HasunumaClinical Pharmacology Center, Oita University Hospital, Japan.
Y InoueGeneral Clinical Research Center (GCRC), Oita University Hospital, Japan.
T KotegawaDepartment of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University, Japan.
K OhashiDepartment of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University, Japan.
N UemuraDepartment of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University, Japan.
Oita University Hospital · JPOita University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pharmacokinetic exposures to fexofenadine (FEX) are reduced by apple juice (AJ); however, the relationship between the AJ volume and the degree of AJ-FEX interaction has not been understood. In this crossover study, 10 healthy subjects received single doses of FEX 60 mg with different volumes (150, 300, and 600 mL) of AJ or water (control). To identify an AJ volume lacking clinically meaningful interaction, we tested a hypothesis that the 90% confidence interval (CI) for geometric mean ratio (GMR) of FEX AUCAJ /AUCwater is contained within a biocomparability bound of 0.5-2.0, with at least one tested volume of AJ. GMR (90% CI) of AUCAJ 150mL /AUCwater , AUCAJ 300mL /AUCwater , and AUCAJ 600mL /AUCwater were 0.903 (0.752-1.085), 0.593 (0.494-0.712), and 0.385 (0.321-0.462), respectively. While a moderate to large AJ-FEX interaction is caused by a larger volumes of AJ (e.g., 300 to 600 mL), the effect of a small volume (e.g., 150 mL) appears to be not meaningful.

Indexed as

BeveragesHealthy VolunteersMalusAdministration, OralFemaleHumansMaleTerfenadinefexofenadineTerfenadine

Identifiers

PMID27197662
PMCPMC5351340
OpenAlexW2400387540

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.