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

PHASE1CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

January 31, 2004

Study Completion Date

March 31, 2004

Conditions
Healthy
Interventions
DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

0,1mmol/kg at 10 mL/15 sec

DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

same dose as arm 1 at bolus rate (2mL/sec)

DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

0,3mmol/kg at 10 mL/15 sec

DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

same dose as arm 3 at bolus rate (2mL/sec)

DRUG

Moxifloxacin (BAY12-8039)

400 mg at 0,07 mL/sec over 60 min

DRUG

Placebo

0,9% saline at 0,6mL/kg at bolus rate

Trial Locations (1)

33181-3405

Miami

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY