PMID- 16639341 OWN - NLM STAT- MEDLINE DCOM- 20060629 LR - 20201209 IS - 1525-4135 (Print) IS - 1525-4135 (Linking) VI - 42 IP - 1 DP - 2006 May TI - Coadministration of esomeprazole with fosamprenavir has no impact on steady-state plasma amprenavir pharmacokinetics. PG - 61-7 AB - OBJECTIVES: To evaluate the drug interaction between fosamprenavir (FPV) and esomeprazole (ESO) after repeated doses in healthy adults. METHODS: Subjects received ESO 20 mg once daily (qd) for 7 days followed by either ESO 20 mg qd + FPV 1400 mg twice daily (bid) or ESO 20 mg qd + FPV 700 mg bid + ritonavir (RTV) 100 mg bid for 14 days in arms 1 and 2, respectively. After a 21- to 28-day washout, subjects received either FPV 1400 mg bid for 14 days (arm 1) or FPV 700 mg bid + RTV 100 mg bid for 14 days (arm 2). Pharmacokinetic sampling was conducted on the last day of each treatment. RESULTS: Simultaneous coadministration of ESO 20 mg qd with either FPV 1400 mg bid or FPV 700 mg bid + RTV 100 mg bid had no effect on steady-state amprenavir pharmacokinetics. The only effect on plasma ESO exposure was a 55% increase in area under the plasma concentration-time curve during a dosing interval, tau[AUC0-tau], after coadministration of ESO 20 mg qd with FPV 1400 mg bid. CONCLUSIONS: FPV 1400 mg bid or FPV 700 mg bid + RTV 100 mg bid may be coadministered simultaneously with ESO without dose adjustment. However, the impact of staggered administration of proton pump inhibitors (PPI) on plasma amprenavir exposure is unknown at present. FAU - Shelton, Mark J AU - Shelton MJ AD - Clinical Pharmacology and Discovery Medicine, GlaxoSmithKline, Research Triangle Park, NC 27709, USA. Mark.J.Shelton@GSK.com FAU - Ford, Susan L AU - Ford SL FAU - Borland, Julie AU - Borland J FAU - Lou, Yu AU - Lou Y FAU - Wire, Mary B AU - Wire MB FAU - Min, Sherene S AU - Min SS FAU - Xue, Zhengyu G AU - Xue ZG FAU - Yuen, Geoffrey AU - Yuen G LA - eng PT - Journal Article PL - United States TA - J Acquir Immune Defic Syndr JT - Journal of acquired immune deficiency syndromes (1999) JID - 100892005 RN - 0 (Carbamates) RN - 0 (Drug Combinations) RN - 0 (Furans) RN - 0 (Organophosphates) RN - 0 (Sulfonamides) RN - 5S0W860XNR (amprenavir) RN - N3PA6559FT (Esomeprazole) RN - O3J8G9O825 (Ritonavir) RN - WOU1621EEG (fosamprenavir) SB - IM MH - Administration, Oral MH - Adolescent MH - Adult MH - Carbamates/*administration & dosage/adverse effects/blood/*pharmacokinetics MH - Diarrhea/chemically induced MH - Drug Administration Schedule MH - Drug Combinations MH - Esomeprazole/*administration & dosage/adverse effects MH - Female MH - Furans MH - Headache/chemically induced MH - Humans MH - Male MH - Middle Aged MH - Nausea/chemically induced MH - Organophosphates/*administration & dosage/adverse effects MH - Ritonavir/administration & dosage/adverse effects MH - Sulfonamides/*administration & dosage/adverse effects/blood/*pharmacokinetics EDAT- 2006/04/28 09:00 MHDA- 2006/06/30 09:00 CRDT- 2006/04/28 09:00 PHST- 2006/04/28 09:00 [pubmed] PHST- 2006/06/30 09:00 [medline] PHST- 2006/04/28 09:00 [entrez] AID - 10.1097/01.qai.0000219770.97303.43 [doi] PST - ppublish SO - J Acquir Immune Defic Syndr. 2006 May;42(1):61-7. doi: 10.1097/01.qai.0000219770.97303.43.