Bioequivalence and Bioavailability Forum

❝ Out of interest, Caffeine is released and available, so this isn't a clinical trial, but what regulations do apply ?

Dear Paul
According to ICH-GCP a clinical trial is any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining ist safety and/or efficacy.
IMHO the students were treated with a drug (coffeine as pure drug and not as cup of coffee) and nobody thought about the consequences neither for the students nor for themselves.