MedDataX Logo

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.

NCT ID: NCT01494779

Last Updated: 2012-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

GH Deficiency (GHD) Growth Retardation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Somatropin Test

Somatropin of Blausiegel Indústria e Comércio Ltda.

Group Type EXPERIMENTAL

Somatropin

Intervention Type DRUG

single subcutaneous dose of 5mg

Saizen

Somatropin of Merck Serono

Group Type ACTIVE_COMPARATOR

Somatropin

Intervention Type DRUG

single subcutaneous dose of 5mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Somatropin

single subcutaneous dose of 5mg

Intervention Type DRUG

Somatropin

single subcutaneous dose of 5mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

32 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Azidus Brasil

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alexandre Frederico, physian

Role: CONTACT

Phone: 55 19 3871-6399

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alexandre Frederico, phsycian

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Version 1

Identifier Type: -

Identifier Source: secondary_id

SOMBLA0911

Identifier Type: -

Identifier Source: org_study_id