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.

Azidus

Status and phase: Unknown; Phase 1

Conditions: Growth Retardation; GH Deficiency (GHD)

Treatments: Drug: Somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01494779

Version 1

SOMBLA0911

Details and patient eligibility

About

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.).

Full 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.

Enrollment: 32 estimated patients

Sex: Male

Ages: 18 to 32 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Somatropin Test

Experimental group

Description:

Somatropin of Blausiegel Indústria e Comércio Ltda.

Treatment:

Drug: Somatropin

Drug: Somatropin

Saizen

Active Comparator group

Description:

Somatropin of Merck Serono

Treatment:

Drug: Somatropin

Drug: Somatropin