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Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.
Tuberculosis is an infectious disease that still causes many victims in the developing world, especially in Indonesia. Rifampicin, isoniazid and ethambutol are the cornerstone of the current treatment. The disadvantage of the current treatment is the long, six-months, duration of the treatment. This long duration contributes to suboptimal adherence to the TB drugs.Thus, there is a very urgent need to evaluate drugs that may help shortening TB treatment. The fluoroquinolone moxifloxacin has shown early bactericidal activity (EBA) in patients with pulmonary TB, and has shown rapid and reliable sterilization. Rifampicin is a strong inducer of the CYP enzymes, but it also induces phase II metabolism. As moxifloxacin is metabolized by phase II metabolism, rifampicin could cause a decrease in the plasma concentrations of moxifloxacin. Therefore, a pharmacokinetic interaction study is warranted.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rumah Sakit Hasan Sadikin (RSHS)
Published on BioPortfolio: 2014-08-27T03:45:31-0400
This double-blind, randomized controlled trial evaluates moxifloxacin versus isoniazid in daily treatment during the first two months of treatment with rifampin, pyrazinamide and ethambuto...
The purpose of this study is to determine the pharmacokinetics (how a drug is absorbed, distributed, and eliminated by the body) of moxifloxacin alone versus moxifloxacin given with rifape...
This study is a placebo-controlled factorial study, randomized to study drug (moxifloxacin vs. ethambutol) and treatment frequency (daily vs. thrice weekly after an initial two weeks of da...
This substudy of TBTC Studies 27 and 28 compares 1) the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the pharmacokinet...
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Tuberculosis of the mouth, tongue, and salivary glands.
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...