Safety

In addition to the NDI's approval, the following preclinical and clinical safety studies have been conducted.

1. Single dose oral toxicity study in rats (GLP study)
2. 90-day repeated dose oral toxicity study in rats (GLP study)
3. Bacterial reverse mutation (Ames) test (GLP study)
4. Micronucleus test in mice (GLP study)
5. 3-month clinical safety study
6. Phase I clinical safety study
7. Doping test