None listed
Conditions
Brief summary
The intracoronary administration of 200 to 400 mcg of nitroglycerin is recommended before a cinecoronariography to prevent spontaneous or catheter induced spasms and to dilate the epicardic arteries and so optimize the quantification of coronary stenosis. When nitroglycerin is administrated intracoronaryly it enlarges the diameter of the coronary arteries in 10-20%, with minor enlargement in segments with major stenosis. The sublingual propatylnitrate, before the coronariography, can be an alternative to the intracoronary nitroglycerin. The main advantage of this alternative is the simplicity of the administration. However, there is no information about the coronary vasodilator effect of sublingual propatylnitrate. The objective of this project is to compare the vasodilator effect of two formulations, the reference and the generics, of sublingual propatylnitrate during the coronariography.
Interventions
The study has 3 arms and are going to evaluate 2 doses of a propatylnitrate generic formulation (10mg and 20mg) comparing to a propatylnitrate reference formulation (10mg).
generic propatylnitrate 10mg administrated in sublingual route, 1 tablet during coronariography.
generic propatylnitrate 20mg administrated in sublingual route, 1 tablet during coronariography.
generic propatylnitrate means that the active drug is the same from reference propatylnitrate but it will be manufactured by other
The study has 3 arms and are going to evaluate 2 doses of a propatylnitrate generic formulation (10mg and 20mg) comparing to a propatylnitrate reference formulation (10mg). generic propatylnitrate 10mg administrated in sublingual route, 1 tablet during coronariography. generic propatylnitrate 20mg administrated in sublingual route, 1 tablet during coronariography. generic propatylnitrate means that the active drug is the same from reference propatylnitrate but it will be manufactured by other company. Since the propatylnitrate pharmacokinetics does not allow to calculate bioequivalence study it was decided together with Ministry of Helath to conduct a phase III-B study.
Sponsors
Eurofarma Laboratorios Ltda
Study design
Allocation
Randomised controlled trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
subject who was clinical indicated to investigate coronary disease; subject who had not used a nitrate formulation or a calcium channel antagonist 12 hours before coronariography
Exclusion criteria
Acute miocardial infarction in less than 7 days; uncontrolled heart failure; cardiogenic arrest or haemodinamics instability; left coronary branch lesion >50%, non protected; left ventricular ejection fraction <30%; previous diagnosis of anterior decendent artery or cincurnflex occlusion; previous angioplasty with or without stent on the proximal third of the anterior decendent artery or on the circunflex; renal failure with creatinine >1,8mg/dl or patient dojng peritoneal dyalises or hemodyalisis
Outcome results
None listed