r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial
Summary
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.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Conditions
Growth Failure
Intervention
r-hGH liquid (Saizen), r-hGH liquid (Saizen), r-hGH freeze-dried
Location
AAI Pharma Deutschland GmbH & Co. KG
Neu-Ulm
Germany
Status
Completed
Source
EMD Serono
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01034735
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Countercurrent Distribution
A method of separation of two or more substances by repeated distribution between two immiscible liquid phases that move past each other in opposite directions. It is a form of liquid-liquid chromatography. (Stedman, 25th ed)
Freeze Etching
A replica technique in which cells are frozen to a very low temperature and cracked with a knife blade to expose the interior surfaces of the cells or cell membranes. The cracked cell surfaces are then freeze-dried to expose their constituents. The surfaces are now ready for shadowing to be viewed using an electron microscope. This method differs from freeze-fracturing in that no cryoprotectant is used and, thus, allows for the sublimation of water during the freeze-drying process to etch the surfaces.
Chromatography, Liquid
Chromatographic techniques in which the mobile phase is a liquid.
Liquid Crystals
Materials in intermediate state between solid and liquid.
Culture Media
Any liquid or solid preparation made specifically for the growth, storage, or transport of microorganisms or other types of cells. The variety of media that exist allow for the culturing of specific microorganisms and cell types, such as differential media, selective media, test media, and defined media. Solid media consist of liquid media that have been solidified with an agent such as AGAR or GELATIN.
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