This study compares the effect of Adalat LA to Coracten on drug levels as well as changes in blood pressure and heart rate in fed hypertensive subjects. Subjects are dosed with either Adalat or Coracten for first 2 weeks, followed by the other drug for 2 weeks, and then switched back to the original drug for one day. Blood samples, blood pressure, and heart rate are taken before and after each treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
43
Nifedipine GITS 30 mg followed by Coracten 30 mg then back to nifedipine GITS 30 mg
Coracten 30 mg followed by nifedipine GITS 30 mg then back to Coracten 30 mg
Unnamed facility
Cambridge, Cambridgeshire, United Kingdom
Maximum change in plasma norepinephrine in fed state dose administration to within 6 hours after the first dose
Time frame: Up to 6 hours after first dose
Single dose: change in epinephrine, SBP, DBP, HR, and plasma nifedipine concentration time profile including Cmax and tmax under fed conditions
Time frame: After first dose
Multi-dose: the change in norepinephrine, epinephrine, SBP, DBP, HR, and plasma nifedipine concentration time profile including Cmax and tmax under fed conditions
Time frame: After 2 weeks dosing
The switch: the change in norepinephrine, epinephrine, SBP, DBP, HR, and plasma nifedipine concentration time profile including Cmax and tmax under fed conditions after switching from Coracten to nifedipine and vice versa
Time frame: Week 2 plus 1 day to week 4
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