Assessment of the Effect of 25 mg and 200 mg of BI 10773 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Five-period Crossover Phase-I-study With Moxifloxacin as Positive Control
Abstract
The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c) interval more than placebo
Conditions: Healthy.
Primary outcome: Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing; Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing.
Enrollment: 30 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 30 participants or records.
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