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 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.).

Study Overview

• Status: Unknown
• Conditions: Growth Retardation; GH Deficiency (GHD)
• Intervention / Treatment: Drug: Somatropin

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 groups.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Valinhos, São Paulo, Brazil
      • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 32 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Somatropin Test; Somatropin of Blausiegel Indústria e Comércio Ltda.	Drug: Somatropin; single subcutaneous dose of 5mg
Active Comparator: Saizen; Somatropin of Merck Serono	Drug: Somatropin; single subcutaneous dose of 5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: November 28, 2011
• First Submitted That Met QC Criteria: December 16, 2011
• First Posted (Estimate): December 19, 2011

Study Record Updates

• Last Update Posted (Estimate): September 25, 2012
• Last Update Submitted That Met QC Criteria: September 21, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: children
• Other Study ID Numbers: SOMBLA0911; Version 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No