Evidence map›Paper›PMID 33029953›Full record

Trial reportClinical pharmacology in drug development2021

Biopharmaceutical Characteristics of Nifurtimox Tablets for Age- and Body Weight-Adjusted Dosing in Patients With Chagas Disease.

Heino Stass, Ethel Feleder, Facundo Garcia-Bournissen, Johannes Nagelschmitz, Boris Weimann, Gustavo Yerino, Jaime Altcheh

Open access · hybridAbstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology in drug development, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.7field-weighted citation impact, top 14% 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

9 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Current drug metabolism · 2023
    Article
  5. Review
  6. Article
  7. Article
  8. Evaluation of the Anti-Pharmaceutics · 2022
    Article
  9. 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

7 authors at 4 institutions in 3 countries.

Heino StassBayer AG, Wuppertal, Germany.
Ethel FelederFP Clinical Pharma, Buenos Aires, Argentina.
Facundo Garcia-BournissenDivision of Pediatric Clinical Pharmacology, Department of Pediatrics, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, Canada.
Johannes NagelschmitzBayer AG, Wuppertal, Germany.
Boris WeimannChrestos Concept GmbH and Co. KG, Essen, Germany.
Gustavo YerinoFP Clinical Pharma, Buenos Aires, Argentina.
Jaime AltchehCONICET-GCBA, Hospital de Niños Ricardo Gutiérrez and Instituto Multidisciplinario de Investigación en Patologías Pediátricas, Buenos Aires, Argentina.
Bayer (Germany) · DEHospital General de Niños Ricardo Gutierrez · ARInstituto Cardiovascular de Buenos Aires · ARDeutsche Montan Technologie (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Treatment of Chagas disease with nifurtimox requires age- and body weight-adjusted dosing, resulting in complex dosing instructions. Appropriate formulations are needed for precise and compliant dosing, especially in pediatric patients. We characterized the biopharmaceutical features of a standard nifurtimox 120-mg tablet and a 30-mg tablet developed to improve dose accuracy. Two open-label, randomized crossover studies were conducted in adult outpatients with Chagas disease. One study investigated whether 4 × 30-mg tablets and 1 × 120-mg tablet were bioequivalent and whether tablets can be administered as an aqueous slurry without affecting bioavailability. The second study investigated the effect of a high-calorie/high-fat diet versus fasting on the absorption of nifurtimox after a single 4 × 30-mg dose. Interventions were equivalent if the 90% confidence interval (CI) of their least-squares (LS) mean ratios for both AUC

Indexed as

Food-Drug InteractionsAdultArea Under CurveBiological AvailabilityChagas DiseaseCross-Over StudiesFastingFemaleHumansMaleMiddle AgedNifurtimoxTabletsTherapeutic EquivalencyTrypanocidal AgentsYoung AdultNifurtimoxTabletsTrypanocidal Agentsbioavailabilityexposurefastingfood effectTrypanosoma cruziwater dispersible

Identifiers

PMID33029953
PMCPMC8246722
OpenAlexW3091934681

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.