Tuberculosis Clinical Trial
Official title:
The Influence of Fasting and Food on the Pharmacokinetics of Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol in Newly Diagnosed TB Patients
WHO recommends to take TB drugs while fasting: if TB drugs are taken with food, perhaps drug
concentrations are too low; on the other hand: if this is not tolerated, drugs could also be
taken with food.
Do lower drug concentrations - with improved adherence to therapy - outweigh the
disadvantage of lower drug blood concentrations over time? How exactly do the drug
concentrations over time (pharmacokinetics) compare between fasting and fed conditions,
especially in the early stage of TB treatment when patients are relatively sick, and
relatively poorly tolerate TB drugs?
To evaluate the influence of concomitant food ingestion on the pharmacokinetics of HRZE in newly diagnosed TB patients To evaluate the influence of early disease on the PK parameters of HRZE in TB patients To compare the pharmacokinetics of HRZE in the early stage of disease with the pharmacokinetics of HRZE in more stable condition in newly diagnosed TB patients To evaluate adverse events of HRZE in TB patients ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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