A toxic analysis of plasma samples was done on the last day of dosing. The time periods for the intravenous blood collection were 10, 30, 60 min, 4, 8, 24h post-dose. The sponsor had had the tests done in a lab in US and they asked that the samples be repeated that lab. The groups for the study were: group1 (vehicle), group2 (low dose), group3 (medium dose), group4 (high dose), group5 (high dose), with a 14 day recovery period, 10 males and 10 females per group and finally group6- toxiciokinetic group only (vehicle and high dose administration).
The study in this case was able to give information on any possible health hazards that may arise as a result of repeated exposure over a comparatively repeated time period. The method comprised basic repeated dose toxicity study. The outcomes for histology indicated that light microscopy of tissue sections increased recruitment of inflammatory cells in the liver. There were no changes in the spleen, kidney, or any other organ examined. The change in daily body weight was decreased in animals on the higher dose compared to animals administered vehicle or lower doses of the test item. Toxic kinetic analysis indicated that the profile (the Cmax and t Â½) for the test item did not differ. Analysis of the dose formulation indicated that the doses administered were as stated in the study plan.