This study is a Phase I randomized clinical trial aiming to investigate the short-term effects of three commonly prescribed statins i.e (Atorvastatin, Rosuvastatin, and Simvastatin) at different dose levels i.e lo,median and high doses on cardiovascular parameters i.e Blood pressure and ECG morphology in healthy volunteers. The study will assess changes in blood pressure and ECG morphology following two days of statin administration under controlled conditions.
The goal of this study is to evaluate the effects of these three statins on the cardiovascular parameters in a dose-dependent manner. In this Phase 1 clinical trial we will enroll healthy volunteers who will be randomized to receive one of three statins at low, moderate, or high doses for two days. .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
The Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Shaheed Benazir Bhutto University Sheringal Dir Upper
Dīr, Khyber Pakhtunkhwa, Pakistan
Blood Pressure Measurements
Blood Pressure of the subjects will be determined by sphygmomanometer
Time frame: before dosing and 2 days after dosing achieving peak plasma concentrations respectively]
Electrocardiograms (ECGs) Measurements
ECGs of the subjects will be determined by 12 Leads ECG Machine.QT interval and QRS complex in milliseconds will be analyzed to determine the effects of these statins on ECG morphology
Time frame: before dosing and 2 days after dosing achieving peak plasma concentrations respectively]
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.