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Preclinical studies

Earlier preclinical studies showed the following results:

The specific activity (anticonvulsant effect):

as part of the study the effect on convulsions caused by maximal electroshock, on pentylenetetrazole seizure, on 5- oxytriptophan convulsions, on nicotine convulsions, on arecoline tremor, on convulsions caused by camphor, on epileptogenic penicillin center, neurotoxic effects and protective index was studied. The results showed that the drug "Galodif" has a spectrum of activity, which is close to benzobarbital and phenobarbital. It exceeds the reference drugs along the efficiency (in the maximal electroshock test) and the margins of safety.

Acute toxicity:

Studies were carried out on rats and mice (male-female). The studies found that "Galodif" is a low-toxic substance after a single intragastric administration of the substance. Average lethal dose for male mice was 2570 ± 180 mg / kg for female mice was 2495 ± 172 mg / kg, the average lethal dose for rats have not been achieved by intragastric administration of 4000 mg / kg, which determines the absence of differences by gender, but the presence of differences in species basis. In acute experiments, the drug "Galodif" did not have a local irritant action after a single intragastric administration. Irritation or necrosis at macroscopic examination did not take place at the mucous membrane of the stomach and the rest of the parts of the gastrointestinal tract.

Chronic toxicity:

the studies were carried out on rats, rabbits and dogs. At the three-month administration of the drug "Galodif" we revealed no violations of the functional state of the major organs and body systems.

The specific types of toxicity:

Studies of mutagenicity and potential carcinogenicity allow us to conclude that the drug "Galodif" in the range of tested doses and concentrations does not show the effects indicating its genotoxic and carcinogenic activity.

Allergenic effect:

Studies were carried out on guinea pigs. Results of the study showed that the drug does not have allergenic properties.

The list of pre-clinical studies on the drug Galodif

  • Experimental investigation of the specific activity of the drug Galodif (Tomsk Medical Institute, Tomsk, 1977).
  • Investigation of bioavailability and chronic toxicity of Galodif (Tomsk Medical Institute, Tomsk, 1977).
  • The report of the experimental investigation of Galodif characterizing its harmlessness (Tomsk Medical Institute, Tomsk, 1987).
  • Preliminary report on the study of the acute and chronic toxicity and anticonvulsant activity of Ggalodif samples (All-Russian Research Center of Safety of biologically active substances (RRC SAS), Staraya Kupavna, 1990).
  • The study of the mutagenic activity of Galodif (RRC SAS, Staraya Kupavna, 1999).
  • The study of teratogenic and embryotoxic properties of Galodif and its effect on reproductive function - (All-Russian Research Center of Safety of biologically active substances (RRC SAS), Staraya Kupavna, 2000).
  • Some aspects of the pharmacokinetics of the original anticonvulsant Galodif (experimentally-clinical research (Mental Health Research Institute, Tomsk, 2000).
  • The study of allergenic effect of substance Galodif (State Educational Institution of Higher Professional Education NNSMA, Nizhny Novgorod, 2011).
  • The study of general and reproductive toxicity, the specific activity of the drug Galodif (SSMU, Tomsk, 2011).
  • Investigation of mutagenicity and potential carcinogenicity of the drug Galodif (Research Institute of Pharmacology n.a. Zakusov V.V., Moscow, 2011).
  • The study of the mechanisms of the biological action of the drug Galdodif (effect on the level of alcoholic motivation and alcohol addiction of rats during the experiment and of patients with alcoholism (FSBI "Mental Health Research Institute", Tomsk, 2013).