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.

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Male

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.).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Azidus Brasil

Criteria

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).