Study to Assess Safety, Tolerability and Pharmacokinetics of Treamid in Healthy Volunteers
Status:
Completed
Trial end date:
2016-11-21
Target enrollment:
Participant gender:
Summary
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and
tolerability of increasing doses of Treamid after single and repeated oral administration in
healthy volunteers. The volunteers received the study drug once, and then continued daily
intake for 14 days after a 6-day break. The primary objective of the study was to evaluate
the safety and tolerability profile of Treamid after single and multiple administration based
on the frequency and severity of adverse events and changes in vital signs, laboratory
results, electrocardiography and results of the physical examination. The secondary objective
of the study was to assess pharmacokinetics of active pharmaceutical substance of Treamid.