ArticleAntimicrobial agents and chemotherapy2013
Evaluation of pharmacokinetic interaction between PA-824 and midazolam in healthy adult subjects.
Article in Antimicrobial agents and chemotherapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed, 24 citations in OpenAlex.
- Phase 1 Study of the Effects of the Tuberculosis Treatment Pretomanid, Alone and in Combination With Moxifloxacin, on the QTc Interval in Healthy Volunteers.Clinical pharmacology in drug development · 2021Trial
- Pretomanid Pharmacokinetics in the Presence of Rifamycins: Interim Results from a Randomized Trial among Patients with Tuberculosis.Antimicrobial agents and chemotherapy · 2021Trial
- In Vitro and Clinical Evaluation of Potential Interactions of Bemnifosbuvir with Drug-Metabolizing Enzymes.Journal of clinical pharmacology · 2026Article
- An Evaluation of the Drug Interaction Potential of Encorafenib in Combination With Binimetinib Using the Inje Cocktail in Patients With Cancer.Clinical pharmacology and therapeutics · 2026Article
- Pretomanid for the treatment of drug resistant pulmonary tuberculosis: a comprehensive review.Archives of microbiology · 2025Review
- Pretomanid for tuberculosis treatment: an update for clinical purposes.Current research in pharmacology and drug discovery · 2022Review
- Profiling Pretomanid as a Therapeutic Option for TB Infection: Evidence to Date.Drug design, development and therapy · 2021Review
- Molecule Property Analyses of Active Compounds forJournal of medicinal chemistry · 2020Review
- Modeling and Simulation of Pretomanid Pharmacokinetics in Pulmonary Tuberculosis Patients.Antimicrobial agents and chemotherapy · 2018Article
- Recent developments and future prospects in the treatment of visceral leishmaniasis.Therapeutic advances in infectious disease · 2016Review
- Investigational drugs for visceral leishmaniasis.Expert opinion on investigational drugs · 2015Article
- A clinical therapeutic protein drug-drug interaction study: coadministration of denosumab and midazolam in postmenopausal women with osteoporosis.Pharmacology research & perspectives · 2014Article
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This study assessed the safety, tolerability, and pharmacokinetic interaction between PA-824, a novel antitubercular nitroimidazo-oxazine, and midazolam, a CYP3A4 substrate, in 14 healthy adult male and female subjects. The study followed up on observations in vitro that PA-824 caused weak and time-dependent inhibition of CYP3A4. Subjects received a single oral dose of midazolam (2 mg), followed by a 2-day washout. After the washout, all subjects received PA-824 (400 mg) once daily for 14 consecutive days. On day 14, all subjects received the final PA-824 dose coadministered with a 2-mg oral dose of midazolam. The pharmacokinetic endpoints AUC0-t, AUC(0-∞), and C(max) for midazolam and 1-hydroxy midazolam were compared between midazolam administered alone versus midazolam coadministered with PA-824. Statistical analysis demonstrated that the mean midazolam values of C(max), AUC(0-t), and AUC(0-∞) parameters were reduced by ca. 16, 15, and 15%, respectively, when PA-824 was coadministered with midazolam. The total exposure (AUC) of 1-hydroxy midazolam was 13 to 14% greater when coadministered with PA-824 compared to midazolam administered alone. The Cmax of 1-hydroxy midazolam was similar between treatments. Based on these results, PA-824 does not inhibit or induce CYP3A4 to a clinically meaningful extent and is not likely to markedly affect the pharmacokinetics of CYP3A4 metabolized drugs.
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