NAC (N-Acetil Cisteína)
Pharmacokinetics and bioequivalence of two N-acetylcysteine tablets in healthy Chinese volunteers under fasting and fed conditions
Resumen del estudio
chromatography-tandem mass spectrometry method. The 90% confidence intervals for the geometric mean ratios (test/reference) of the maximum plasma concentration, the area under the concentration-time curve from time zero to the last measurable concentration, and from time zero to infinity were all within the accepted bioequivalence range of 80%-125%. Furthermore, both the test and reference formulations were well tolerated, and no serious adverse events were reported. These results demonstrate that the test and reference NAC tablets are bioequivalent and exhibit similar pharmacokinetic profiles and safety in healthy
Detalles bibliográficos
- Autores: Yin X, Xia R, Song H, Zhang Y, Guo D, Gan F
- Publicado en: Clinical pharmacology in drug development
- PMID: 41138059
- DOI: 10.1002/cpdd.1619
