Aliskiren

Study Procedures

)Before Starting the Study )Screening 

The clinical investigator will investigate the following: - subject health status. - Medical and surgical history - physical examination - Height and Weight - vital signs )BP )both setting and standing), Body Temp. and pulse rate)

 

ECG, Alcohol, Drug of Abuse and Nicotine Testing will be performed Blood sample will be withdrawn for the Medical Lab Purposes.

At Admission  The

following will be tested at the admission and before taking testing drugs: - vital signs: BP )at setting and standing), Body Tem. And Pulse rate. - Alcohol, Drug of Abuse and Nicotine Testing, - physical examination - weight - ECG - Blood and urine Samples for Medical Lab purposes

During Study Period-I   

Fasting at least 10 hours Pre-Dose and 4hrs post Dose. fluids is prevented 2hrs pre- and post Dose except that for drug administration. During study, the following Tests will be performed: - Vital Signs: )Predose )setting and standing BP), 01hr, 03hr, 06hr, 08hr, 12hr )setting and standing BP) and 24hr )setting and standing BP) post dose. - Blood Sampling: pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24, 48, 72, 96 hours post dose. - Meals: 4hrs and 12hrs post dose.

At the Discharge  ECG  Vital

Signs  Blood sample for the medical lab purposes  Snack  Weight

Wash Out Period = 10 Days

Admission Period-II  Revision

for `the medical history and the inclusion/exclusion criteria.  Physical examination  Drug of abuse and nicotine testing  Weight  Vital Signs )setting and standing BP).  ECG  Blood sample for the medical lab purposes

Day 1-6 Period-II  Pre-Dose

Vital signs.  Breakfast and followed by  Single dose of the 240mg Verapamil each morning after 30 minutes of the breakfast.

Day-6  Admission

and fasting for at least 10 hrs prior to dosing

Day-7  Vital

Signs: Pre-dose )setting and standing BP) and 12hrs post dose )setting and standing BP).  Pre-dose Blood sampling for Laboratory Purposes.  Blood Sampling: pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0 hrs post dose.  Meals: 4hr and 12hrs post dose  Fluids: 2hrs pre- and post dose is not allowed except that given with drug administration.

Day-8   

Fasting at least 10 hours Pre-Dose and 4hrs post Dose. fluids is prevented 2hrs pre- and post Dose except that for drug administration. During study, the following Tests will be performed: - Vital Signs: )Predose )setting and standing BP), 01hr, 03hr, 06hr, 08hr, 12hr )setting and standing BP), 24hr )setting and standing BP), 48hr)setting and standing BP), 72hr )setting and standing BP) and 96 )setting and standing BP)hr post dose. - Blood Sampling )Aliskiren): pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24, 48, 72, 96 hours post dose. - Blood Sampling )Verapamil): pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24 - Meals: 4hrs and 12hrs post dose.

At Discharge  ECG  Vital

Signs  Blood sample for the medical lab purposes  Snack

Follow Up  ECG  Vital

Signs )setting and standing BP).  Blood sample for the medical lab purposes  Snack  Physical Examination