임상시험에 사용되는 의약품의 안전성가 유효성을 증명할 목적으로, 해당 약물의 약동, 약력, 약리, 임상적 효과를 확인하고 이상반응을 조사하기 위하여 사람을 대상으로 하는 시험 또는 연구

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one of more investigational medicinal product(s), and/ or to identify any adverse reactions to one or more investigational medicinal product(s), and/or to study absorption, distribution, metabolism and excretion of one of more investigational medicinal product(s) with the object of ascertaining its (their) safety and/ or efficacy.