ArticleAdvances in therapy2021
Pharmacokinetics and Safety of Single and Multiple Doses of Oral N-Acetylcysteine in Healthy Chinese and Caucasian Volunteers: An Open-Label, Phase I Clinical Study.
Article in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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Who cites it
17 citing papers in PubMed, 26 citations in OpenAlex.
- Redefining the role of the thiol-based agentRSC medicinal chemistry · 2026Review
- Systematic evaluation and comparison of theCurrent research in food science · 2026Article
- Effect of N-Acetyl-L-Cysteine (NAC) on Inflammation After Intraperitoneal Mesh Placement in anMedical sciences (Basel, Switzerland) · 2025Article
- Intestinal permeability of N-acetylcysteine is driven by gut microbiota-dependent cysteine palmitoylation.Nature communications · 2025Article
- N-acetylcysteine in paediatrics: a review of efficacy, safety and dosing strategies in respiratory care.Drugs in context · 2025Review
- 'Comprehensive review of emerging drug targets in traumatic brain injury (TBI): challenges and future scope.Inflammopharmacology · 2024Review
- N-acetylcysteine in Kidney Disease: Molecular Mechanisms, Pharmacokinetics, and Clinical Effectiveness.Kidney international reports · 2024Review
- N-Acetylcysteine and Atherosclerosis: Promises and Challenges.Antioxidants (Basel, Switzerland) · 2023Review
- N-acetylcysteine Pharmacology and Applications in Rare Diseases-Repurposing an Old Antioxidant.Antioxidants (Basel, Switzerland) · 2023Review
- Development of DipeptidePharmaceutics · 2023Article
- Premature ovarian insufficiency: a review on the role of oxidative stress and the application of antioxidants.Frontiers in endocrinology · 2023Review
- Introduction to Traditional Medicine and Their Role in Prevention and Treatment of Emerging and Re-Emerging Diseases.Biomolecules · 2022Review
- N-Acetylcysteine Interference with a Glucose Dehydrogenase Linked Glucose Meter.Journal of diabetes science and technology · 2022Article
- Effects of NAC and Gallic Acid on the Proliferation Inhibition and Induced Death of Lung Cancer Cells with Different Antioxidant Capacities.Molecules (Basel, Switzerland) · 2021Article
- The Pharmacokinetic Profile and Bioavailability of Enteral N-Acetylcysteine in Intensive Care Unit.Medicina (Kaunas, Lithuania) · 2021Article
- Absorption of N-acetylcysteine in Healthy andVeterinary sciences · 2021Article
- Review
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Authors and funding
3 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionFew studies have evaluated whether the pharmacokinetics of N-acetyl-cysteine (NAC) are different in Chinese and Caucasian individuals.
methodsThis single- and multiple-dose, single-centre, open-label, phase I clinical study was conducted in healthy adult volunteers. All participants received oral NAC 600-mg uncoated tablets, which were administered first as a single dose and, following a 48-h wash-out period, twice daily for 3 days. Blood and urine were collected after single- and multiple-dose NAC administration. Adverse event (AE) data were collected throughout the study.
resultsFifteen Chinese and 15 Caucasian (mostly Italian) individuals (males 66.7%, mean age 36.8 years) participated in the study. Pharmacokinetic characteristics of NAC were similar in the two cohorts. Following both single- and multiple-dose administration, plasma concentration of NAC increased rapidly, reaching a peak at approximately 1.0 h. Maximum plasma concentration and extent of exposure were higher after multiple doses than after a single dose. The accumulation ratio was relatively consistent in both Chinese (mean ± standard deviation 1.5 ± 0.4) and Caucasian (1.4 ± 0.2) participants. The half-life was 15.4 h in Chinese and 18.7 h in Caucasian participants, and the fraction of NAC excreted in urine in the 36 h following administration was 3.7% in Chinese and 3.8% in Caucasian participants. Two Caucasian participants had a total of 3 AEs (headache, presyncope and dysmenorrhoea). No AEs occurred in Chinese participants.
conclusionsThe pharmacokinetic characteristics of NAC are similar in healthy Chinese and Caucasian individuals after single and repeated administration. NAC has a favourable tolerability profile.
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