Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg Compared To Product Sandostatin LAR ®

Study Overview
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Brief Summary
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Check the pharmacodynamics of the drug octreotide acetate LAR 30 mg imported and distributed by Chemical Laboratory Pharmaceutical Bergamo Ltda. compared to the drug Sandostatin LAR ® (octreotide acetate 30 mg) manufactured by Novartis Biociências S / A, using as activity analysis of growth hormone (GH) and growth factor insulin-like 1 (IGF-1 ) after a single dose of the drug in patients with acromegaly

Detailed Description
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Secondly, it will be observed safety (tolerability) in clinical patients by comparing the clinical and laboratory parameters before and after the study and the incidence of adverse events after a single dose

Official Title
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Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg, Imported And Distributed By The Laboratory Chemical Pharm. Bergamo, Compared To Product Sandostatin LAR®30 MG Manufactured By Novartis Biosciences S/A

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: Octreotide acetate LAR
* Drug: Sandostatin LAR ® (octreotide acetate LAR) 30 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Accept the Terms of Consent; be aged over 18, regardless of sex; Patients with acromegaly who presented GH levels ≥ 2.5 ng / mL or no suppression of GH levels to less than 1 ng / mL after tolerance test glucose and IGF-I levels for age and sex; Patients undergoing hypophysectomy followed by radiotherapy or not and to keep níves increased GH and IGF-I; Patients waiting hypophysectomy with increased levels of GH and IGF-I Exclusion Criteria: Have participated in any experimental study or have ingested any drug trial within six months prior to the start of the study; Have made use of medications that influence the results, regular 4 weeks prior to the start of the study or having used any medication a week before the start of the study; Have been treated with somastostatina analog or dopamine agonist in the last 2 months; Present history of myocardial infarction, angina and / or heart failure; Patients who present calculation of the gallbladder and have not undergone cholecystectomy; Pregnant women and nursing; Patients who have allergies to medicine; Patients with a history of acute pancreatitis; Patient with altered levels of amylase

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octreotide acetate LAR 30 MG<br>Test | Drug: Octreotide acetate LAR<br>* 30 mg, single dose<br>|
| Active Comparator: Sandostatin LAR ® (octreotide acetate LAR) 30 MG<br> | Drug: Sandostatin LAR ® (octreotide acetate LAR) 30 MG<br>* 30 mg, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of serum levels of GH and IGF-I. |  | Before drug administration, after drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and severity of side effects during use of the product in order to ensure the security of it. |  | After drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after. |