Evidence map›Paper›PMID 26428357›Full record

ArticleEuropean journal of drug metabolism and pharmacokinetics2016

Pharmacokinetics of Glycopyrronium Following Repeated Once-Daily Inhalation in Healthy Chinese Subjects.

Romain Sechaud, Surendra Machineni, Hanns-Christian Tillmann, Hisanori Hara, Xuemei Tan, Rong Zhao, Shuang Ren, Jie Hou

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In one paragraph

Article in European journal of drug metabolism and pharmacokinetics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.2field-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

5 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. COPD and glycopyrronium responsiveness assessment: An appraisal.Lung India : official organ of Indian Chest Society
    Article
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

8 authors at 5 institutions in 3 countries.

Romain SechaudNovartis Institutes for Biomedical Research, WSJ-386-12.48.13, Novartis Campus, 4002, Basel, Switzerland. romain.sechaud@novartis.com.
Surendra MachineniNovartis Healthcare Pvt. Ltd, Hyderabad, India.
Hanns-Christian TillmannNovartis Institutes for Biomedical Research, WSJ-386-12.48.13, Novartis Campus, 4002, Basel, Switzerland.
Hisanori HaraNovartis Institutes for Biomedical Research, WSJ-153.3.02.2, Novartis Campus, 4002, Basel, Switzerland.
Xuemei TanNovartis Institutes for Biomedical Research, Beijing, People's Republic of China.
Rong ZhaoNovartis Institutes for Biomedical Research, Shanghai, People's Republic of China.
Shuang RenNovartis Institutes for Biomedical Research, Shanghai, People's Republic of China.
Jie HouTICH, TEDA, Tianjin, People's Republic of China.
Novartis (China) · CNNovartis Institutes for BioMedical ResearchNovartis (India) · INNovartis (Switzerland) · CHTianjin Economic-Technological Development Area · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesGlycopyrronium is a once-daily long-acting muscarinic antagonist for the maintenance treatment of patients with chronic obstructive pulmonary disease. This study assessed the pharmacokinetics of inhaled glycopyrronium 50 µg once-daily for 14 days in healthy Chinese subjects.

methodsIn this open-label study, 12 Chinese healthy subjects (six males and six females; mean age 23.1 years [range 18-26 years]) were enrolled and completed the study. Glycopyrronium in plasma was determined using validated liquid chromatography-mass spectrometry method with a lower limit of quantification of 1.5 pg/mL. Plasma pharmacokinetic parameters were determined on Day 1 after first dose and on Day 14 (steady state) after last dose using non-compartmental analysis. Trough pharmacokinetic samples (Days 5, 7, 10 and 12) were collected. Safety was also assessed.

resultsGlycopyrronium was rapidly absorbed into the systemic circulation after inhalation and its plasma concentrations decreased rapidly thereafter. Median time to reach maximum concentration (T

conclusionsComparison of systemic exposure to glycopyrronium in Chinese versus the non-Chinese population did not indicate clinically relevant ethnic differences. Multiple inhaled doses of glycopyrronium were safe and well tolerated.

Indexed as

Absorption, PhysiologicalAdministration, InhalationAdolescentAdultArea Under CurveAsian PeopleBiological AvailabilityChinaFemaleGlycopyrrolateHalf-LifeHumansMaleMuscarinic AntagonistsYoung AdultGlycopyrrolateMuscarinic Antagonists

Identifiers

PMID26428357
OpenAlexW2254396775

What OpenQuestion holds

Textmetadata
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.