Effect of Multiple Dosing With 240 mg QD BI 201335 on the Steady-state Pharmacokinetics of 800 mg QD Darunavir Coadministered With 100 mg QD Ritonavir (DRV/r) in Healthy Male and Female Volunteers (an Open-label, Multiple-dose, Single Group, Single Fixed Sequence Phase I Study)
Overview
- Phase
- Phase 1
- Intervention
- BI 201335
- Conditions
- HIV Infections
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- AUCτ,ss of Darunavir
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 201335
capsule for oral administration
Intervention: BI 201335
Darunavir 400 mg
tablet for oral administration
Intervention: Darunavir
Ritonavir 100 mg
tablet for oral administration
Intervention: Ritonavir
Outcomes
Primary Outcomes
AUCτ,ss of Darunavir
Time Frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities
Cτ,ss of Darunavir
Time Frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir
Cmax,ss of Darunavir
Time Frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
maximum measured concentration of the analyte in plasma at steady-state
Secondary Outcomes
- Tmax,ss of Darunavir(0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r))