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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2008
The primary objective of the trial was to assess the bioequivalence for two concentrations (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH freeze-dried multidose formulation (Saizen® 8 mg, 8.8 mg/1.51 mL) as reference. Each volunteer received three r hGH treatments, with each treatment being administered as a single subcutaneous dose of 4 mg r-hGH in a randomized sequence with at least one week of wash-out period between successive treatments.
Epistemonikos ID: 4ca657cad2a1a7cece1d5306bdf385f0520b2c3e
First added on: May 05, 2024