Relative bioavailability of bedaquiline tablets suspended in water: Implications for dosing in children.

ABSTRACT:

Aims

Bedaquiline 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.

Methods

A 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 t

SUBMITTER: Svensson EM 

PROVIDER: S-EPMC6138504 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature