IRCT20130626013776N20
Recruiting
未知
Study of the pharmacokinetic and pharmacodynamic and safety properties of Somatin® (5 mg/1.5 ml cartridges, AryaTinaGene Biopharmaceutical Co) in comparison to Norditropin® (5 mg/1.5 ml cartridges, Novo Nordisk) in healthy volunteers
AryaTinaGene Biopharmaceutical Co0 sites30 target enrollmentTBD
Conditions..
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- ..
- Sponsor
- AryaTinaGene Biopharmaceutical Co
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Volunteers, 18\-50 years of age.
- •The subject is able and willing to provide signed informed consent.
- •The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent.
- •The subject has stable residence and telephone.
- •Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
Exclusion Criteria
- •History of allergy or sensitivity to somatropin.
- •History of any drug hypersensitivity or intolerance which, in the opinion of the investigator,would compromise the safety of the subject of the study.
- •Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
- •Presence of gastrointestinal disease or history of malabsorption within the last year.
- •History of a medical disorders occurring within the last year that required hospitalization or medication.
- •Use of pharmacologic agents known to significantly induce or inhibit drug\-metabolizing enzymes within 30 days prior to dosing.
- •Receipt of any drug as part of a research study within 30 days prior to the present study.
- •Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Bioequivalence Study of Pegfilgrastim in Healthy Human VolunteersIRCT20130626013776N8AryaTinaGene Biopharmaceutical Co24
Completed
Not Applicable
Bioequivalence Study of Filgrastim in Healthy Human VolunteersHealthy volunteers.IRCT20130626013776N7AryaTinaGene Biopharmaceutical Co24
Active, not recruiting
Not Applicable
A Study of the Pharmacodynamics, Pharmacokinetics, and Safety & Efficacy of ARC1779 Injection in Patients with von Willebrand Disease Type 2B - ARC1779 for VWD-2Bvon Willebrand Disease type 2BEUCTR2008-008532-82-ATMedical University of Vienna, Dept. of Clinical Pharmacology
Not yet recruiting
Not Applicable
Examining the pharmacokinetic and pharmacodynamic profile of biperidegeheugen/ memoryNL-OMON24672Maastricht University27
Recruiting
Not Applicable
Examining the pharmacokinetic and pharmacodynamic profile of biperideNL-OMON47428niversiteit Maastricht42