دورية أكاديمية
Pharmacokinetics of darunavir after administration of an oral suspension with low-dose ritonavir and with or without food.
| العنوان: | Pharmacokinetics of darunavir after administration of an oral suspension with low-dose ritonavir and with or without food. |
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| المؤلفون: | Kakuda TN; Janssen Research & Development, LLC, Titusville, NJ, USA., Sekar V; Janssen Research & Development, LLC, Titusville, NJ, USA., Lavreys L; Janssen Infectious Diseases BVBA, Beerse, Belgium., De Paepe E; Janssen Infectious Diseases BVBA, Beerse, Belgium., Stevens T; Janssen Infectious Diseases BVBA, Beerse, Belgium., Vanstockem M; Janssen Infectious Diseases BVBA, Beerse, Belgium., Vangeneugden T; Janssen Infectious Diseases BVBA, Beerse, Belgium., Hoetelmans RM; Janssen Infectious Diseases BVBA, Beerse, Belgium. |
| المصدر: | Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2014 Sep; Vol. 3 (5), pp. 346-52. Date of Electronic Publication: 2014 Feb 10. |
| نوع المنشور: | Clinical Trial, Phase I; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley Country of Publication: United States NLM ID: 101572899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2160-7648 (Electronic) Linking ISSN: 2160763X NLM ISO Abbreviation: Clin Pharmacol Drug Dev Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2013- : Hoboken, NJ : Wiley Original Publication: Thousand Oaks, Calif. : Sage Publications, c2012- |
| مواضيع طبية MeSH: | Food-Drug Interactions*, Darunavir/*administration & dosage , Darunavir/*pharmacokinetics , HIV Protease Inhibitors/*administration & dosage , HIV Protease Inhibitors/*pharmacokinetics , Ritonavir/*administration & dosage, Administration, Oral ; Adult ; Area Under Curve ; Biological Availability ; Cross-Over Studies ; Darunavir/adverse effects ; Darunavir/blood ; Fasting/blood ; Female ; HIV Protease Inhibitors/adverse effects ; HIV Protease Inhibitors/blood ; Healthy Volunteers ; Humans ; Male ; Metabolic Clearance Rate ; Middle Aged ; Netherlands ; Pharmaceutical Solutions ; Postprandial Period ; Tablets ; Young Adult |
| مستخلص: | This 2-part, phase 1, open-label, randomized, crossover study (NCT00752310) assessed ritonavir-boosted darunavir bioavailability (oral suspension vs. tablets), and steady-state darunavir pharmacokinetics (suspension). Part 1: 20 healthy adults randomly received 3 treatments with a ≥7-day washout between treatments; twice-daily ritonavir (100 mg, days 1-5) with darunavir (600 mg, day 3) as 2 × 300-mg tablets (fed, reference), or 6 mL of a 100-mg/mL suspension (fed or fasted, test). Part 2: 18 healthy volunteers received twice-daily darunavir (suspension, 600 mg days 1-6, one dose day 7) with twice-daily ritonavir (100 mg, days 1-9). Darunavir pharmacokinetics were evaluated (part 1 day 3; part 2 day 7). Safety/tolerability were assessed. In part 1, 90% confidence intervals for darunavir Cmax and AUC were all within 80-125% for suspension (fed or fasted) versus tablets (fed). Steady-state darunavir (suspension) pharmacokinetics in part 2 were similar to historic controls (tablets). No clinically relevant differences in adverse events or laboratory abnormalities occurred between treatments. Darunavir administered as an oral suspension or tablets (both with low-dose ritonavir) showed comparable bioavailability in healthy adults after a single dose. Steady-state darunavir pharmacokinetics (suspension, 600/100 mg twice daily) were consistent with historic controls; this formulation is considered suitable for pediatric use and for adults who cannot swallow tablets. (© 2014, The American College of Clinical Pharmacology.) |
| فهرسة مساهمة: | Keywords: HIV protease inhibitor; bioavailability; darunavir; pharmacokinetics |
| المشرفين على المادة: | 0 (HIV Protease Inhibitors) 0 (Pharmaceutical Solutions) 0 (Tablets) O3J8G9O825 (Ritonavir) YO603Y8113 (Darunavir) |
| تواريخ الأحداث: | Date Created: 20160430 Date Completed: 20180116 Latest Revision: 20180724 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1002/cpdd.88 |
| PMID: | 27129006 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2160-7648 |
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| DOI: | 10.1002/cpdd.88 |