ArticleCurrent therapeutic research, clinical and experimental2016
Effervescent N-Acetylcysteine Tablets versus Oral Solution N-Acetylcysteine in Fasting Healthy Adults: An Open-Label, Randomized, Single-Dose, Crossover, Relative Bioavailability Study.
Article in Current therapeutic research, clinical and experimental, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02723669 (Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover Study to Determine the Relative Bioavailability of AR10), which is not on this map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover Study to Determine the Relative Bioavailability of AR10 (Acetylcysteine Effervescent Tablets) Compared to Reference Product in Healthy, Adult Subjects, Fasting
Who cites it
10 citing papers in PubMed.
- N-Acetylcysteine to Reduce Kidney and Liver Injury Associated with Drug-Resistant Tuberculosis Treatment.Pharmaceutics · 2025Article
- Advances in the Use ofAntioxidants (Basel, Switzerland) · 2023Review
- N-acetylcysteine Pharmacology and Applications in Rare Diseases-Repurposing an Old Antioxidant.Antioxidants (Basel, Switzerland) · 2023Review
- Review
- Antioxidant Molecules as a Source of Mitigation of Antibiotic Resistance Gene Dissemination.Antimicrobial agents and chemotherapy · 2021Article
- 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.Advances in therapy · 2021Article
- N-Acetylcysteine as Modulator of the Essential Trace Elements Copper and Zinc.Antioxidants (Basel, Switzerland) · 2020Article
- Antioxidant supplements and endurance exercise: Current evidence and mechanistic insights.Redox biology · 2020Review
- Glutathione: Antioxidant Properties Dedicated to Nanotechnologies.Antioxidants (Basel, Switzerland) · 2018Review
- N-Acetylcysteine Prevents the Increase in Spontaneous Oxidation of Dopamine During Monoamine Oxidase Inhibition in PC12 Cells.Neurochemical research · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOral solution N-acetylcysteine (NAC) is an antidote for acetaminophen overdose, but its unpleasant taste and aroma can impede delivery even after the coadministration of antiemetic medications. Flavored effervescent NAC tablets dissolved in water might be a more palatable formulation than oral solution NAC diluted with soft drink.
objectivesTo evaluate the relative bioavailability of these 2 formulations and assess subjective preferences between them.
methodsThirty healthy adult volunteers (mean [SD] = 35.2 [9.14] years) were enrolled in this open-label, randomized, single-dose, crossover study, with a 7-day washout period. Volunteers were randomized to receive 11 g effervescent test formulation or the reference product under fasting conditions, after which 19 serial blood samples were collected over 48 hours. Total plasma NAC concentrations were evaluated by LC-MS, and pharmacokinetic parameters were calculated. The 2 formulations were considered bioequivalent if the 90% CIs of log-transformed ratios of pharmacokinetic parameters were within the predetermined bioequivalence range (80%-125%) established by the US Food and Drug Administration. Within 15 minutes of dosing, subjects were also asked to rank formulation attributes on a 5-point hedonic scale, with mean group differences analyzed by Wilcoxon signed rank test. Safety-profile assessment included treatment-emergent adverse events, physical examination, chemistry, and hematology parameters.
resultsThe concentration-versus-time profiles were similar for the 2 formulations, with mean Cmax of 26.5 μg/mL for effervescent NAC tablets and 28.4 μg/mL for oral solution NAC. The 90% CIs for the pharmacokinetic parameters met the criteria for concluding bioequivalence, and subjects preferred effervescent NAC tablets in terms of taste (P = 0.0247), flavor (P = 0.0082), texture (P = 0.009), and overall likeability (P = 0.0012), but there was no difference for smell (P = 0.0533). All treatment-emergent adverse events were mild, with no differences between the treatment groups.
conclusionsData from this study of a single dose of 11 g oral NAC demonstrated that effervescent NAC tablets and oral solution NAC met the regulatory criteria for bioequivalence in fasting healthy adult subjects. Effervescent NAC tablets appear to be a more palatable alternative for treatment of acetaminophen overdose. ClinicalTrials.gov identifier: NCT02723669. (Curr Ther Res Clin Exp. 2016; 83C:1-7) © 2016 Elsevier HS Journals, Inc.
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