Healthy
Conditions
Brief summary
Study to determine the effect of BILR 355/r on Combivir® pharmacokinetics and the effect of Combivir® on BILR 355 BS pharmacokinetics.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males or females who meet the inclusion/
Exclusion criteria
, females are not pregnant or nursing, and agree to use a double-barrier method of birth control (condoms or diaphragm plus spermicide) throughout the trial (alone or in addition to other methods of birth control such as oral contraceptives) 2. Age ≥18 and \<60 years 3. Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2 4. Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local regulations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of the analyte in plasma over one dosing interval at steady state (AUC0-12h,ss) | up to day 18 |
| Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss) | up to day 18 |
Secondary
| Measure | Time frame |
|---|---|
| Terminal half-life of the analyte in plasma at steady state (t1/2,ss) | up to day 18 |
| Apparent volume of distribution during the terminal phase λz at steady state following an extravascular dose (Vz/Fss) | up to day 18 |
| Measured concentration of the analyte in plasma 12 hours post last dose at steady state (Cp12h, ss) | up to day 18 |
| Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss) | up to day 18 |
| Number of subjects with abnormal laboratory parameters | up to 49 days |
| Number of subjects with clinically significant findings in vital signs | up to 49 days |
| Number of subjects with adverse events | up to 49 days |
| Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss) | up to day 18 |
Outcome results
None listed