Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg, Imported And Distributed By The Laboratory Chemical Pharmaceutical Bergamo Ltda., Compared To Product Sandostatin LAR ® (Octreotide Acetate LAR) 30 MG Manufactured By Novartis Biosciences S

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azidus Brasil
• Treatments: Octreotide

Criteria

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