NCT01086982

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

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

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Octreotide acetate LAR	30 mg, single dose
DRUG	Sandostatin LAR ® (octreotide acetate LAR) 30 MG	30 mg, single dose

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-03-15
• Last updated: 2022-11-03

Locations

1 site across 1 country: Brazil