A Two Way Cross Over Pharmacokinetic Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
The purpose of the study is to look at the levels of an HIV medication (raltegravir) in the
blood, and how it is affected if raltegravir is taken at the same time as another medicine
for high blood pressure (amlodipine). Many patients with HIV will also have high blood
pressure, so it is important to know which drugs for each of these conditions can be taken
together without affecting how well they work individually.
Over a 3 week period, participants took amlodipine for 2 weeks, and raltegravir for 2 weeks,
with the middle week being on both drugs. The investigators will look at and compare the
levels of these two drugs in the blood after subjects have taken them separately and both
together.
This study is randomised into two groups with both study medications received by all
participants in a three-period crossover pattern; randomisation determined which medication
was taken first. Once randomised allocation was performed, medications were administered in
an open-label fashion.