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- Title
Effect of Tipranavir/Ritonavir Combination on the Pharmacokinetics of Tadalafil in Healthy Volunteers.
- Authors
Garraffo, R.; Lavrut, T.; Ferrando, S.; Durant, J.; Rouyrre, N.; MacGregor, T.R.; Sabo, J. P.; Dellamonica, P.
- Abstract
This study evaluated the effects of single-dose administration and steady-state concentrations of tipranavir 500 mg and ritonavir 200 mg (TPV/r) combination on the pharmacokinetics of tadalafil 10 mg (TAD) in an open-label study. Seventeen healthy male volunteers received sequential dosing of the studied product: TAD (day 1) alone in a single dose for 7 days followed by TAD (day 8) in a single dose with TPV/r (500/200 mg twice daily, days 8-18). Pharmacokinetic parameters were determined in a noncompartmental analysis. The geometric mean ratio and 90% confidence interval were used to evaluate drug interactions. The effect of a single dose of TAD on the pharmacokinetics of TPV/r resulted in a small decrease in exposure after either first-dose or steady-state TPV/r (geometric mean ratios [90% confidence interval]: area under the concentration–time curve, 0.85 [0.74-0.97]). In contrast, coadministration of TAD exposure was increased significantly (2.33 [2.02-2.69]) when administered with the first dose of TPV/r but not when TPV/r steady state was reached (1.01 [0.83-1.21]). Antiretroviral activity may not be reduced, but the dose of TAD should be reduced at the start of TPV/r therapy and then a full dose can be resumed after steady state is reached.
- Subjects
FRANCE; ANTIVIRAL agents; COMBINATION drug therapy; COMPUTER software; CONFIDENCE intervals; CROSSOVER trials; DRUG interactions; MALE reproductive organ diseases; HEME; HIGH performance liquid chromatography; HIV infections; MASS spectrometry; HEALTH outcome assessment; RESEARCH funding; T-test (Statistics); TIME; DATA analysis; PROTEASE inhibitors; SEXUAL dysfunction; TREATMENT effectiveness; TIPRANAVIR (Drug)
- Publication
Journal of Clinical Pharmacology, 2011, Vol 51, Issue 7, p1071
- ISSN
0091-2700
- Publication type
Article
- DOI
10.1177/0091270010379808