A Fixed Dose Combination Amlodipine + Enalapril Bioavailability Study
Status:
Completed
Trial end date:
2013-05-24
Target enrollment:
Participant gender:
Summary
The study is designed to estimate the bioavailability of amlodipine and enalapril maleate
fixed dose combination (FDC) relative to co-administration of amlodipine and enalapril
maleate tablets. The rational for this study is to provide a more convenient dosing regimen
for patients. This is an open-label, randomized, single dose, two-way crossover study, in
which 16 healthy adult male and female subjects will be enrolled and dosed under fasting
conditions. Each subject will participate in two treatment periods of 7 days each. There will
be at least 14 days of wash out period between the two dosing periods and a follow-up period
of up to 21 days after treatment period 2. The total duration of study will be approximately
35 days from the start of the first treatment.