Status:
COMPLETED
Influence of Drug Transporter Expression on the Pharmacokinetics of the HIV Protease Inhibitor Kaletra
Lead Sponsor:
Heidelberg University
Conditions:
Healthy
Pharmacokinetics
Eligibility:
All Genders
18-50 years
Brief Summary
The aim of this study is to determine the pharmacokinetics of Kaletra™ (HIV protease inhibitors lopinavir and ritonavir) in different body compartments and to assess the role of four different drug tr...
Detailed Description
Objective: Measurement of AUC, Cmax, tmax, t1/2 and clearance (Cl) of the protease inhibitor Kaletra™ (lopinavir and ritonavir) each in the plasma of healthy individuals * establish free and total p...
Eligibility Criteria
Inclusion
- Good state of health
Exclusion
- Drug treatment with known inhibitors or inducers of cytochrome P450 isozymes or ABC-transporters within the preceding 2 months
- Any acute or chronic illness
- Smoking
- Pregnancy
- Alcohol or drug abuse
Key Trial Info
Start Date :
January 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00176033
Start Date
January 1 2005
Last Update
February 13 2009
Active Locations (1)
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1
Clinical Research Center, Department of Internal Medicine VI
Heidelberg, Germany, 69120