r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

August 31, 2008

Conditions
Growth FailureGrowth Hormone Deficiency
Interventions
BIOLOGICAL

r-hGH liquid (Saizen)

Treatment Arm A: r-hGH liquid multidose formulation 5.83 mg/mL, needle injection (0.686 mL)

BIOLOGICAL

r-hGH liquid (Saizen)

Treatment Arm B: r-hGH liquid multidose formulation 8.0 mg/mL, needle injection (0.5 mL)

BIOLOGICAL

r-hGH freeze-dried

Treatment Arm C: r-hGH 8 mg (8.8 mg/1.51 ml) freeze-dried formulation ( reconstituted in metacresol 0.3% w/v) needle injection (0.686 mL)

Trial Locations (1)

Unknown

AAI Pharma Deutschland GmbH & Co. KG, Neu-Ulm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EMD Serono

INDUSTRY

NCT01034735 - r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial | Biotech Hunter | Biotech Hunter