Cardiovascular Safety Study of Magnevist® Injection at Two Dose Levels and Two Injection Rates in Normal Subjects

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine what effect Magnevist (gadopentetate dimeglumine) injection has on the way the heart conducts the electrical impulses that allow it to beat effectively. The study will compare Magnevist injection's effect to that of placebo (a saline injection).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• Subjects with an electrocardiogram [ECG] (normal sinus rhythm [SR], QTc > 450 msec) without clinically significant abnormalities

• Non-smoker

Exclusion Criteria:

• History of cardiovascular disease- Pregnant or nursing- Had any contraindication to moxifloxacin