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 Blood sample will be withdrawn for the Medical Lab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