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.

Growth Retardation Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01494779
• Other study ID #: SOMBLA0911
• Secondary ID: Version 1
• Status: Not yet recruiting
• Phase: Phase 1
• First received: November 28, 2011
• Last updated: September 21, 2012
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: September 2012
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: Alexandre Frederico, physian
• Phone: 55 19 3871-6399
• Email: alexandre[@]lalclinica.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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 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.).

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 groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 32 Years

Eligibility

Inclusion Criteria:

1. Research subjects who agree with all study procedures, sign and date, of their own free will, the IC;

2. Research subjects were male, aged between 18 and 32 years;

3. Research subjects with body mass index greater than or equal to 20 and less than or equal to 25;

4. Considered healthy subjects, both clinical and laboratory.

Exclusion Criteria:

1. Have donated or lost 450 mL or more blood in the 6 months preceding the study;

2. Having participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;

3. 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;

4. Present history of alcohol abuse, drug or drugs;

5. Have a history of liver disease, renal, pulmonary, gastrointestinal, hematologic, or psychiatric;

6. Have made previous use of somatropin;

7. Make use of energy supplements and / or be frequent consumers of soy products (eg replacement of animal milk for soy milk).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• GH Deficiency (GHD)
• Growth Retardation

Intervention

Drug:
• Somatropin
single subcutaneous dose of 5mg
• Somatropin
single subcutaneous dose of 5mg

Locations

Country	Name	City	State
Brazil	LAL Clínica Pesquisa e Desenvolvimento Ltda	Valinhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	PK: 0, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 9, 12, 15, 18, 24 hours. PD: 0, 6, 12, 24 hours.	Yes
Secondary	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.		15 weeks	Yes