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

Status Completed

Clinical 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01034735
Study type	Interventional
Source	EMD Serono
Contact
Status	Completed
Phase	Phase 1
Start date	July 2008

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02243852` - Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21)	N/A
Completed	`NCT01440686` - Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers	Phase 1
Completed	`NCT00990340` - Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method	Phase 4
Completed	`NCT00149708` - Consequence of Lifetime Isolated Growth Hormone Deficiency	N/A
Completed	`NCT00235599` - The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.	N/A
Completed	`NCT00459940` - The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients	N/A
Completed	`NCT01157793` - A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood	Phase 4
Completed	`NCT00004365` - Study of Pituitary Size and Function in Familial Dwarfism of Sindh	N/A
Recruiting	`NCT00227253` - Chromosome 18 Clinical Research Center
Recruiting	`NCT04121780` - Growth Hormone Replacement Therapy for Retried Professional Football Players	Phase 2
Completed	`NCT02934399` - Dynamic Hormone Diagnostics in Endocrine Disease
Completed	`NCT01090778` - Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)	Phase 2
Completed	`NCT01062529` - Peripheral Metabolic Effects of Somatostatin	N/A
Completed	`NCT00965484` - Genotropin Study Assessing Use of Injection Pen	Phase 3
Completed	`NCT00616278` - National Cooperative Growth Study in CKD	N/A
Completed	`NCT02693522` - Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency	Phase 3
Recruiting	`NCT02908958` - Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency	Phase 4
Terminated	`NCT01243892` - A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device	N/A
Withdrawn	`NCT00638287` - Inter-Assay Growth Hormone and IGF-I Variability	N/A
Completed	`NCT00929799` - Growth Hormone and Glucose Metabolism	Phase 4