- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01494779
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Alexandre Frederico, physian
- Phone Number: 55 19 3871-6399
- Email: alexandre@lalclinica.com.br
Study Locations
-
-
São Paulo
-
Valinhos, São Paulo, Brazil
- LAL Clínica Pesquisa e Desenvolvimento Ltda
-
Contact:
- Alexandre Frederico, phsycian
- Phone Number: 55 19 3871-6399
- Email: alexandre@lalclinica.com.br
-
Principal Investigator:
- Alexandre Frederico, phsycian
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Somatropin Test
Somatropin of Blausiegel Indústria e Comércio Ltda.
|
single subcutaneous dose of 5mg
|
Active Comparator: Saizen
Somatropin of Merck Serono
|
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.
Time Frame: PK: 0, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 9, 12, 15, 18, 24 hours. PD: 0, 6, 12, 24 hours.
|
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.
Time Frame: 15 weeks
|
15 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SOMBLA0911
- Version 1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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