Phase I Trail for Intramuscular Administration of Midazolam Using An Autoinjector

PHASE1CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

July 31, 2006

Study Completion Date

December 31, 2006

Conditions
Seizures
Interventions
DRUG

Midazolam

The study drug was administered IM into the anterior thigh using the preloaded autoinjector. The autoinjectors were preloaded with midazolam 5 mg or 10 mg with a total volume of 1 or 2 mL. Healthy subjects were assigned to one of six target dosage groups (0.10, 0.18, 0.25, 0.33, 0.40, 0.49 mg/kg) and, based on their weight, received the necessary combination of fixed 5 or 10 mg doses to provide the assigned target dose.

Trial Locations (1)

21201

BASi Baltimore Clinical Research Unit, Baltimore

All Listed Sponsors
lead

U.S. Army Office of the Surgeon General

FED

NCT00534378 - Phase I Trail for Intramuscular Administration of Midazolam Using An Autoinjector | Biotech Hunter | Biotech Hunter