Evidence map›Paper›PMID 31819674›Full record

ArticleClinical pharmacology : advances and applications2019

Metabolism and Excretion of Intravenous, Radio-Labeled Amisulpride in Healthy, Adult Volunteers.

Gabriel M Fox, Ad F Roffel, Jan Hartstra, Linda A Bussian, Sjoerd P van Marle

Registry-linked trialOpen access · goldAbstract readCase Reports
In one paragraph

Article in Clinical pharmacology : advances and applications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02881840 (An Open Label, Single Dose, Single Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C] APD421 Administered Via the Intravenous Route to Healthy Male Subjects), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.3field-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.

NCT02881840 phase1completednot on this map

An Open Label, Single Dose, Single Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C] APD421 Administered Via the Intravenous Route to Healthy Male Subjects

TypeinterventionalSponsorAcacia Pharma LtdRan2016 to 2016Enrolled6ConditionsPost-operative Nausea and VomitingArms14C-APD421
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. 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

5 authors at 1 institution in 1 country.

Gabriel M FoxDepartment of Clinical Development, Acacia Pharma Ltd, Cambridge, UK.ORCID 0000-0003-3768-0639
Ad F RoffelPRA Health Sciences, Groningen, the Netherlands.ORCID 0000-0001-9796-3855
Jan HartstraPRA Health Sciences, Groningen, the Netherlands.
Linda A BussianComedica Ltd, Cambridge, UK.
Sjoerd P van MarlePRA Health Sciences, Groningen, the Netherlands.
Acacia Pharma (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIntravenous amisulpride, a dopamine D PATIENTS AND

methodsSix healthy male volunteers aged 18-65 years were given a single 10 mg dose of

resultsThe mean recovery of radioactivity in excreta was 96.4% (range 92.0-98.5%), of which 73.6% (range 70.6-79.2%) was recovered from urine and 22.8% (range 18.9-25.7%) from feces. Four metabolites of amisulpride were detected in urine, representing 15.0% of the excreted dose; three of these were also present in feces, representing 6.1% of the excreted dose. No metabolites were detected in plasma. Excretion was initially rapid, with about two-thirds of the drug-related material eliminated within 12 hrs, primarily in the urine. A second, slower phase of excretion was predominantly fecal and was essentially complete by 96 hrs after dosing. The terminal plasma elimination half-life of parent amisulpride was 3.7 hrs and that of total

conclusionIntravenous amisulpride undergoes limited metabolism and is excreted primarily via the renal route. CLINICAL TRIAL REGISTRY NUMBER: ClinicalTrials.gov NCT02881840.

Indexed as

amisulprideantiemeticseliminationmetabolismradio-labeled

Identifiers

PMID31819674
PMCPMC6896931
OpenAlexW2989871681

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.