A Randomized, Single-Dose, Comparative, Positive and Placebo Controlled, Four-Way, Four Period, Cross-Over Study to Evaluate the Effect of DIC075V on QTc Intervals in Healthy Subjects
This study is conducted to evaluate the effectiveness of DIC075V on ventricular
repolarization in healthy subjects compared to placebo after a single dose of DIC075V
administered intravenously (IV) and to evaluate ECG assay sensitivity by evaluating the
baseline-adjusted effect of a single oral (PO) moxifloxacin 400 mg dose on ventricular
repolarization in healthy subjects compared to placebo. Other secondary objectives are as
- To evaluate the effect of DIC075V on ventricular repolarization in healthy subjects
compared to placebo at the Tmax of diclofenac and hydroxypropyl-β-cyclodextrin (HPβCD).
- To determine if there is a pharmacokinetic/pharmacodynamic (PK/PD) relationship between
the duration of the QTc intervals and diclofenac and HPβCD plasma concentrations.
- Obtain additional pharmacokinetic (PK) information on diclofenac and HPβCD in healthy
- Provide additional safety information.
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