Safety, Tolerability and PK 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol® in Healthy Subjects
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
The objective is to determine the safety, tolerability and pharmacokinetics (PK) of 2 single
doses of ZTI-01 (1g and 8g infused over 1-hr) and a single dose of the Reference Label Drug,
Monurol® (oral sachet, 3g). Subjects will be randomized to a treatment sequence prior to
dosing on Day 1 of Period 1 prior to study screening.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)