Pharmacokinetics of clofazimine tablet formulation in children with rifampicin-resistant tuberculosis in CATALYST, a multi-site international trial

We evaluated the pharmacokinetics of a novel child-friendly 50 mg clofazimine tablet formulation that disperses quickly in water, compared to traditional gel capsules, in 36 children routinely treated for rifampicin-resistant tuberculosis. No substantial pharmacokinetic difference was observed between tablets and gel capsules, supporting the tablet formulation use for paediatric dosing.

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Publication Details

Journal
Journal of the Pediatric Infectious Diseases Society
Published
2026-09-09
DOI
https://doi.org/10.1093/jpids/piag089
Primary Topic
Tuberculosis Research and Epidemiology
Type
article
Field-Weighted Citation Impact
0.00
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article

Pharmacokinetics of clofazimine tablet formulation in children with rifampicin-resistant tuberculosis in CATALYST, a multi-site international trial

Aarti Kinikar, Elin M. Svensson, Ingrid Courtney, Yuanxi Zou et al.
Journal of the Pediatric Infectious Diseases Society
Tuberculosis Research and Epidemiology
article

Pharmacokinetics of clofazimine tablet formulation in children with rifampicin-resistant tuberculosis in CATALYST, a multi-site international trial

Aarti Kinikar, Elin M. Svensson, Ingrid Courtney, Yuanxi Zou, Pragathi Kamath, Anneke Catharina Hesseling, Anthony J. Garcia‐Prats, Vandana Kulkarni, Lubbe Wiesner, Paolo Denti, Louvina E. van der Laan, Mats O. Karlsson, Heather Draper, Mandar Paradkar, Megan Palmer, Dessa Jean O Casalme, Melchor V G Frias
article en

Abstract

We evaluated the pharmacokinetics of a novel child-friendly 50 mg clofazimine tablet formulation that disperses quickly in water, compared to traditional gel capsules, in 36 children routinely treated for rifampicin-resistant tuberculosis. No substantial pharmacokinetic difference was observed between tablets and gel capsules, supporting the tablet formulation use for paediatric dosing.

Journal of the Pediatric Infectious Diseases Society
Uppsala University (SE), University of Wisconsin–Madison (US), Desmond Tutu HIV Foundation (ZA), Johns Hopkins University (US), Radboud University Nijmegen (NL), University of Cape Town (ZA), B. J. Medical College & Sassoon Hospital (IN), Stellenbosch University (ZA), Radboud University Medical Center (NL), De La Salle University – Dasmariñas (PH)
Openalex Percentile: Top 11%
Tuberculosis Research and Epidemiology
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