Status:
UNKNOWN
Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A.
Lead Sponsor:
Azidus Brasil
Conditions:
GH Deficiency (GHD)
Growth Retardation
Eligibility:
MALE
18-32 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect between two preparations of somatropin (T and C) after a single administration of 5 mg in healthy subje...
Detailed Description
Secondly, the investigators will observe the clinical safety and tolerability after single dose administration in subjects, by comparing clinical parameters and the incidence of adverse events between...
Eligibility Criteria
Inclusion
- Research subjects who agree with all study procedures, sign and date, of their own free will, the IC;
- Research subjects were male, aged between 18 and 32 years;
- Research subjects with body mass index greater than or equal to 20 and less than or equal to 25;
- Considered healthy subjects, both clinical and laboratory.
Exclusion
- Have donated or lost 450 mL or more blood in the 6 months preceding the study;
- Having participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;
- Having made use of regular medication less than two weeks to interfere with the pharmacokinetics / pharmacodynamics of the drug under study, such as glucocorticoids, anabolic steroids, androgens, estrogens and thyroid hormones;
- Present history of alcohol abuse, drug or drugs;
- Have a history of liver disease, renal, pulmonary, gastrointestinal, hematologic, or psychiatric;
- Have made previous use of somatropin;
- Make use of energy supplements and / or be frequent consumers of soy products (eg replacement of animal milk for soy milk).
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01494779
Start Date
March 1 2013
End Date
August 1 2013
Last Update
September 25 2012
Active Locations (1)
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1
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil