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.
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Azidus Brasil.
Recruitment status was: Not yet recruiting
Information provided by (Responsible Party):
First received: November 28, 2011
Last updated: September 21, 2012
Last verified: September 2012
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 subjects by altering serum somatropin pharmacokinetic parameters (AUC0-24h, AUC0-inf, Cmax, Tmax and T1 / 2) and pharmacodynamic (measurement of serum levels of IGF-1 presented by the concentration-time profile, AUC 0-24h and AUC0-inf.).
GH Deficiency (GHD)
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Outcome Measures:
- The primary efficacy endpoint will be based in the investigation of pharmacokinetics and pharmacodynamics of somatropin in research subjects after administration of single dose, sc, of the drug. [ Time Frame: PK: 0, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 9, 12, 15, 18, 24 hours. PD: 0, 6, 12, 24 hours. ] [ Designated as safety issue: Yes ]
Pharmacokinetic evaluation will be based on data obtained from the average dosage of somatropin plasma. Thus, the time of collection facilities provide the pharmacokinetic parameters AUC0-24h, AUC0-inf, Cmax, Tmax and T1 / 2, which will be compared between the two formulations.
The quantification of serum somatropin kit will be performed by ELISA validated using human serum as a biological matrix.
The evaluation of the pharmacodynamics will be performed by quantifying serum levels of IGF-1 presented by the concentration-time profile, AUC 0-24h and AUC0-inf.
Secondary Outcome Measures:
- After administration of the drug will be evaluated for safety and tolerability of the drug through the presence of hematoma, pain, itching and local redness, as well as the incidence of adverse events directly related to somatropin. [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
Experimental: Somatropin Test
Somatropin of Blausiegel Indústria e Comércio Ltda.
single subcutaneous dose of 5mg
Active Comparator: Saizen
Somatropin of Merck Serono
single subcutaneous dose of 5mg
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 groups.
|Ages Eligible for Study:
||18 Years to 32 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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).
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494779
|LAL Clínica Pesquisa e Desenvolvimento Ltda
|Valinhos, São Paulo, Brazil |
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 28, 2011
||September 21, 2012
||Brazil: National Health Surveillance Agency
Keywords provided by Azidus Brasil:
ClinicalTrials.gov processed this record on December 09, 2016