Race Difference Moxifloxacin-induced QT Prolongation Between Healthy Chinese and Caucasian Volunteers
Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
A double-center, randomized, double-blinded, 2-way crossover, placebo-controlled Study:
Comparison of single oral dose 400mg Moxifloxacin-induced QT prolongation between healthy
Chinese volunteers and Caucasian Volunteers Study Objective:Primary Objective:To compare the
difference of ΔΔQTcF (Baseline-adjusted, placebo-corrected effect on QTcF) between Chinese
group and Caucasian group under the same exposure (Cmax) of Moxifloxacin.Secondary
Objectives:1)To compare the difference of ΔΔQTcF, heart rate, PR, RR, QRS and Moxifloxacin
plasma concentration between Chinese group and Caucasian group.2)To compare slopes of
Moxifloxacin plasma Concentration/QTcF value between healthy Chinese volunteers and Caucasian
Volunteers.
Phase:
Phase 1
Details
Lead Sponsor:
Haiyan Li
Collaborators:
BioClinica, Inc. Food and Drug Administration (FDA) Peking University Spaulding Clinical Research LLC
Treatments:
Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination