The rule provides a framework for potential licensure of medical products when definitive efficacy studies that would involve exposing healthy human volunteers are unethical and field trials after accidental human exposure are not feasible. (sciencedaily.com)
The molecule was produced by Portuguese drugmaker Bial and tested in healthy human volunteers in a phase I study by the French contract research company Biotrial in Rennes. (sciencemag.org)
This has since been tested in healthy human volunteers who were given E. angustifolia extract for one week. (mindbodygreen.com)