ArticleBritish journal of clinical pharmacology2018
Relative bioavailability of bedaquiline tablets suspended in water: Implications for dosing in children.
Article in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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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.
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Who cites it
17 citing papers in PubMed.
- Global child-friendly anti-TB medicines - where do we stand?IJTLD open · 2025Article
- Current Treatment of Drug-Resistant Tuberculosis in Children.Indian journal of pediatrics · 2024Review
- Bioanalysis of bedaquiline in human plasma by liquid chromatography-tandem mass spectrometry: Application to pharmacokinetic study.Journal of mass spectrometry and advances in the clinical lab · 2024Article
- Stable, compounded bedaquiline suspensions to support practical implementation of pediatric dosing in the field.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023Article
- Nanocapillary sampling coupled to liquid chromatography mass spectrometry delivers single cell drug measurement and lipid fingerprints.The Analyst · 2023Article
- Advances of new drugs bedaquiline and delamanid in the treatment of multi-drug resistant tuberculosis in children.Frontiers in cellular and infection microbiology · 2023Review
- Pharmacokinetics and Safety of Bedaquiline in Human Immunodeficiency Virus (HIV)-Positive and Negative Older Children and Adolescents With Rifampicin-Resistant Tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Observational
- A Scoping Review of the Clinical Pharmacokinetics of Bedaquiline.Clinical pharmacokinetics · 2022Article
- Pharmacodynamics and Bactericidal Activity of Bedaquiline in Pulmonary Tuberculosis.Antimicrobial agents and chemotherapy · 2022Article
- Coronavirus Disease 2019 (COVID-19) Pharmacologic Treatments for Children: Research Priorities and Approach to Pediatric Studies.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Article
- New Drugs for the Treatment of Tuberculosis.Clinics in chest medicine · 2019Review
- Article
- Diagnosis and Management of Multidrug-Resistant Tuberculosis in Children: A Practical Approach.Indian journal of pediatrics · 2019Review
- Current research toward optimizing dosing of first-line antituberculosis treatment.Expert review of anti-infective therapy · 2019Review
- Relative bioavailability of bedaquiline tablets suspended in water: Implications for dosing in children.British journal of clinical pharmacology · 2018Article
- Multidrug-resistant tuberculosis infection and disease in children: a review of new and repurposed drugs.Therapeutic advances in infectious diseaseReview
- Tuberculosis parenteral therapeutic regimens for critical patients or non-functional intestinal tract: Brief review and proposal of protocol.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious DiseasesReview
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
aimsBedaquiline is an important novel drug for treatment of multidrug-resistant tuberculosis, but no paediatric formulation is yet available. This work aimed to explore the possibility of using the existing tablet formulation in children by evaluating the relative bioavailability, short-term safety, acceptability and palatability of suspended bedaquiline tablets compared to whole tablets.
methodsA randomized, open-label, two-period cross-over study was conducted in 24 healthy adult volunteers. Rich pharmacokinetic sampling over 48 h was conducted at two occasions 14 days apart in each participant after administration of 400 mg bedaquiline (whole or suspended in water). The pharmacokinetic data were analysed with nonlinear mixed-effects modelling. A questionnaire was used to assess palatability and acceptability.
resultsThere was no statistically significant difference in the bioavailability of the suspended bedaquiline tables compared to whole. The nonparametric 95% confidence interval of the relative bioavailability of suspended bedaquiline tablets was 94-108% of that of whole bedaquiline tablets; hence, the predefined bioequivalence criteria were fulfilled. There were no Grade 3 or 4 or serious treatment emergent adverse events recorded in the study and no apparent differences between whole tablets and suspension regarding taste, texture or smell.
conclusionsThe bioavailability of bedaquiline tablets suspended in water was the same as for tablets swallowed whole and the suspension was well tolerated. This suggests that the currently available bedaquiline formulation could be used to treat multidrug-resistant tuberculosis in children, to bridge the gap between when paediatric dosing regimens have been established and when a paediatric dispersible formulation is routinely available.
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