Trial reportPharmaceutical research2015
The Influence of Chitosan on the Oral Bioavailability of Acyclovir--a Comparative Bioavailability Study in Humans.
Trial report in Pharmaceutical research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 33 citations in OpenAlex.
- Anti-COVID-19 Credentials of Chitosan Composites and Derivatives: Future Scope?Antibiotics (Basel, Switzerland) · 2023Review
- Lipopolysaccharide Nanosystems for the Enhancement of Oral Bioavailability.AAPS PharmSciTech · 2021Review
- Central Composite Design for Formulation and Optimization of Solid Lipid Nanoparticles to Enhance Oral Bioavailability of Acyclovir.Molecules (Basel, Switzerland) · 2021Article
- Preparation and Antimicrobial Activity of Chitosan and Its Derivatives: A Concise Review.Molecules (Basel, Switzerland) · 2021Review
- Transdermal Film Loaded with Garlic Oil-Acyclovir Nanoemulsion to Overcome Barriers for Its Use in Alleviating Cold Sore Conditions.Pharmaceutics · 2021Article
- Advanced delivery strategies facilitating oral absorption of heparins.Asian journal of pharmaceutical sciences · 2020Review
- Chitosan/Xanthan Gum Based Hydrogels as Potential Carrier for an Antiviral Drug: Fabrication, Characterization, and Safety Evaluation.Frontiers in chemistry · 2020Article
- The Interesting Case of Acyclovir Delivered Using Chitosan in Humans: Is it a Drug Issue or Formulation Issue?Pharmaceutical research · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe effects of chitosan hydrochloride on the oral absorption of acyclovir in humans were studied to confirm the absorption enhancing effects reported for in vitro and rat studies, respectively.
methodsA controlled, open-label, randomized, 3-phase study was conducted in 12 healthy human volunteers. Zovirax 200 mg dispersible tablets co-administered with doses of 400 and 1000 mg chitosan HCl were compared with Zovirax only.
resultsThe expected increased absorption of acyclovir was not observed. On the contrary, mean area under the plasma concentration-time curve (AUC0-12 h) and maximal plasma concentration (Cmax) decreased following concomitant chitosan intake (1402 versus 1017 and 982.0 ng ∙ h/ml and 373 versus 208 and 235 ng/ml, respectively). In addition, Tmax increased significantly in presence of 1000 mg of chitosan from 1 to 2 h.
conclusionsThe results of this study in human volunteers did not confirm an absorption enhancing effect of chitosan. Reference values were comparable to literature data, whereas addition of chitosan resulted in significant opposite effects on Cmax, Tmax and AUC. Additional studies are needed to investigate the cause of the discrepancy. The observed variability and complex potential interactions may complicate the use of chitosan HCl in oral pharmaceutical formulations.
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