Trial reportBritish journal of clinical pharmacology2008
The pharmacokinetics and effects of a long-acting preparation of superoxide dismutase (PC-SOD) in man.
Trial report in British journal of clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 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
12 citing papers in PubMed, 26 citations in OpenAlex.
- Evaluation of lecithinized human recombinant super oxide dismutase as cardioprotectant in anthracycline-treated breast cancer patients.British journal of clinical pharmacology · 2014Trial
- Preventive effect of PC-SOD on oxaliplatin-induced peripheral neuropathy in rats.BMC neuroscience · 2026Article
- Inflammatory bowel diseases: pathological mechanisms and therapeutic perspectives.Molecular biomedicine · 2026Review
- Prophylactic administration of lecithinized superoxide dismutase for a murine model of oxaliplatin-induced myelosuppression.Frontiers in pharmacology · 2025Article
- The Efficacy and Safety of GF101 and Its Antioxidant Effect on In Vitro Fertilization Outcomes: A Double-Blind, Non-Inferiority, Randomized, Controlled Trial with Coenzyme Q10.Antioxidants (Basel, Switzerland) · 2024Article
- 100% oxygen mobilizes stem cells and up-regulates MIF and APRIL in humans: a new point on the hormetic dose curve.Frontiers in cell and developmental biology · 2024Article
- Disengaging the COVID-19 Clutch as a Discerning Eye Over the Inflammatory Circuit During SARS-CoV-2 Infection.Inflammation · 2022Review
- The Effect of Antioxidant Added to Preservation Solution on the Protection of Kidneys before Transplantation.International journal of molecular sciences · 2022Review
- Lecithinized superoxide dismutase in the past and in the present: Any role in the actual pandemia of COVID-19?Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2021Review
- Bolus injection of newly synthesized vitamin E derivative ETS-GS for the treatment of acute severe ulcerative colitis in a mouse model. New vitamin E derivative for acute severe UC.International journal of colorectal disease · 2013Article
- Local delivery of a PKCε-activating peptide limits ischemia reperfusion injury in the aged female rat heart.American journal of physiology. Regulatory, integrative and comparative physiology · 2011Article
- A lecithinized superoxide dismutase (PC-SOD) improves ulcerative colitis.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2008Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo study the pharmacokinetics (PK), safety and tolerability of single rising doses up to 80 mg of superoxide dismutase covalently linked to lecithin (PC-SOD) in healthy White volunteers.
methodsThis double-blind, placebo-controlled, four-period cross-over study was performed in eight healthy volunteers (four male/four female). Three doses of PC-SOD (20, 40 and 80 mg) and placebo were administered intravenously in randomized order. Serum and urinary PC-SOD concentrations were measured predose and up to 96 h after dosing. In addition to standard safety measurements, the urinary excretion of N-acetyl-beta-glucosaminidase, alpha-glutathione S-transferase (alpha-GST) and pi-GST was measured to evaluate renal function. The PK of PC-SOD was analysed using noncompartmental and compartmental methods.
resultsAll treatments were well tolerated, and no obvious relationship between adverse events and treatment was observed. No effects of PC-SOD on renal function could be detected. Dose normalized C(max) and AUC were not different between the different dosages, indicating linearity of plasma concentrations with dose. Estimated PC-SOD clearance was 2.54 ml min(-1)[95% confidence interval (CI) 2.07, 2.83]. The terminal half-life was estimated to be 1.54 days (95% CI 0.93, 2.15). SOD activity was elevated above baseline for 19 +/- 6 h after the 80-mg dose.
conclusionsSingle intravenous administrations of PC-SOD in doses up to 80 mg were well tolerated in healthy White male and female volunteers. With the doses used, SOD activity was linearly related to the dose; after the 80-mg dose it was present for an appreciable period. These findings suggest that it is worthwhile to investigate PC-SOD in clinical conditions characterized by a high radical overload.
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Registered trials
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