Evidence map›Paper›PMID 34357516›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2021

Comparison of the Pharmacokinetic Profiles of Trientine Tetrahydrochloride and Trientine Dihydrochloride in Healthy Subjects.

Karl Heinz Weiss, Catherine Thompson, Peter Dogterom, Yi-Jin Chiou, Tim Morley, Brinley Jackson, Naseem Amin, Camille Omar Farouk Kamlin

Abstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.5field-weighted citation impact, top 19% 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

13 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. [Progress in drug therapy of Wilson's disease].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024
    Review
  12. Review
  13. 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

8 authors at 4 institutions in 3 countries.

Karl Heinz WeissDepartment of Internal Medicine, Salem Medical Center, Heidelberg, Germany.
Catherine ThompsonJune Pharma Consulting Limited, London, UK.
Peter DogteromQPS Netherlands B.V., Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.
Yi-Jin ChiouQPS Taiwan, 12F, No. 3, Park St, Nangang Dist, Taipei, 115, Taiwan.
Tim MorleyOrphalan, 226 Boulevard Voltaire, 75011, Paris, France.
Brinley JacksonOrphalan, 226 Boulevard Voltaire, 75011, Paris, France.
Naseem AminOrphalan, 226 Boulevard Voltaire, 75011, Paris, France.
Camille Omar Farouk KamlinOrphalan, 226 Boulevard Voltaire, 75011, Paris, France. omar.kamlin@gmp-o.com.ORCID http://orcid.org/0000-0002-4872-3860
Krankenhaus Salem · DEPlastic Omnium (France) · FRQPS (Netherlands) · NLQPS Taiwan (Taiwan)

Funding

Orphalan, France Industry Sponsored Study
6 · The paper itself

Abstract

BACKGROUND AND

objectiveWilson disease (WD) is an autosomal recessive inherited disorder of copper metabolism. Chelation of excessive copper is recommended but data on the pharmacokinetics of trientine are limited. The aim of this study was to compare the pharmacokinetics of a new trientine tetrahydrochloride formulation (TETA 4HCl) with those of an established trientine dihydrochloride (TETA 2HCl) salt.

methodsA randomised single-centre crossover study to evaluate the pharmacokinetics, safety and tolerability of two different oral formulations of trientine (TETA 4HCl tablets vs TETA 2HCl capsules) in 23 healthy adult subjects receiving a single dose equivalent to 600 mg of trientine base was performed.

resultsFollowing oral administration, the median time to reach maximum plasma concentration (T

conclusionsCompared with an identical dose of a TETA 2HCl formulation, the TETA 4HCl formulation provided more rapid absorption of trientine and greater systemic exposure in healthy subjects. Clinical Trials Number EudraCT # 2015-002199-25.

Indexed as

Administration, OralAdolescentAdultArea Under CurveChelating AgentsCross-Over StudiesFemaleHalf-LifeHumansMaleSaltsSex FactorsTrientineYoung AdultChelating AgentsSaltsTrientine

Identifiers

PMID34357516
OpenAlexW3187915895

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.