Pharmacokinetics of plasma lopinavir/ritonavir following the administration of 400/100, 200/150, and 200/50 mg twice daily in HIV-negative volunteers
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چکیده
Methods Following written consent, male and female volunteers were administered LPV/r 400/100 (2 LPV/r Meltrex 200/50 tablets; regimen 1), 200/150 (1 Meltrex tablet, 1 100mg ritonavir capsule; regimen 2), and 200/50 (1 Meltrex tablet; regimen 3) mg twice daily (BID) for 7 days sequentially. Each 7-day phase was separated by a 7-day wash-out period and LPV/r steady-state PK was assessed over 12 hours on the last day of each dosing phase (days 7, 21 and 35). PK parameters were compared using Phase 1 as reference by determining geometric mean ratios (GMR) and 90% confidence intervals (CI). Safety and tolerability were assessed throughout the study period.
منابع مشابه
Pharmacokinetics of plasma lopinavir/ritonavir following the administration of 400/100 mg, 200/150 mg and 200/50 mg twice daily in HIV-negative volunteers.
OBJECTIVES Data suggest that some licensed antiretroviral doses could be reduced. We assessed the safety, tolerability and pharmacokinetics of lopinavir/ritonavir at doses of 400/100, 200/150 and 200/50 mg twice daily in HIV-negative volunteers (http://clinicaltrials.gov/ct2/show/NCT00985543). METHODS Male and female volunteers were administered lopinavir/ritonavir at doses of 400/100 mg (two...
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