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.

NCT01494779 | Unknown Phase 1

• 2 other identifiers: SOMBLA0911Version 1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 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.).

Conditions

GH Deficiency (GHD); Growth Retardation

Keywords

children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Somatropin Test

EXPERIMENTAL

Somatropin of Blausiegel Indústria e Comércio Ltda.

Drug: Somatropin

Saizen

ACTIVE COMPARATOR

Somatropin of Merck Serono

Drug: Somatropin

Interventions

Somatropin DRUG

single subcutaneous dose of 5mg

Somatropin Test

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Alexandre Frederico, physian

CONTACT

55 19 3871-6399; alexandre@lalclinica.com.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 19, 2011
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

BR (1)