Pharmacokinetics and bioequivalence of two N‐acetylcysteine tablets in healthy Chinese volunteers under fasting and fed conditions
Rattachement africain : cn. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
N-acetylcysteine (NAC) is a derivative of cysteine with potent mucolytic and antioxidant properties. However, the pharmacokinetics of NAC tablets remain unclear in healthy Chinese subjects. This study aimed to assess the pharmacokinetics, bioequivalence, and safety of a domestically manufactured NAC tablet (600 mg) compared with the reference formulation in healthy Chinese volunteers under both fasting and fed conditions. A single-dose, randomized, open-label, two-formulation, crossover bioequivalence study was conducted, using a two-period, two-sequence design under fasting conditions and a four-period, fully replicated crossover design under fed conditions. Blood samples were collected at predetermined time points and analyzed using a validated liquid 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 Chinese subjects under both fasting and fed conditions.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Pharmacokinetics and bioequivalence of two N‐acetylcysteine tablets in healthy Chinese volunteers under fasting and fed conditions
- Date Crossref
- 25/10/2025
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Xianning Central Hospital pays non établi dans la noticeÉtablissement de santé
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Hubei University of Science and Technology Office of Drug Clinical Trial Institution Xianning Central Hospital pays non établi dans la noticeUniversité ou école supérieure
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Ezhou Central Hospital Department of Pharmacy pays non établi dans la noticeÉtablissement de santé
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Tongji Hospital Department of Neurosurgery pays non établi dans la noticeÉtablissement de santé
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School of Pharmacy pays non établi dans la noticeUniversité ou école supérieure
Xianning Central Hospital, Office of Drug Clinical Trial Institution Xianning Central Hospital — Hubei University of Science and Technology et Department of Pharmacy — Ezhou Central Hospital, avec 2 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.