{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,8,20]],"date-time":"2024-08-20T09:52:09Z","timestamp":1724147529622},"reference-count":19,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,6,19]],"date-time":"2023-06-19T00:00:00Z","timestamp":1687132800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Darunavir\/cobicistat\/emtricitabine\/tenofovir alafenamide (D\/C\/F\/TAF) 800\/150\/200\/10\u00a0mg is a fixed\u2010dose combination (FDC) for the treatment of HIV\u20101 infection in adults and adolescents weighing 40\u00a0kg or greater. This Phase 1, randomized, open\u2010label, 2\u2010treatment, 2\u2010sequence, 4\u2010period replicate crossover study (NCT04661397) evaluated the pivotal bioequivalence of a pediatric D\/C\/F\/TAF 675\/150\/200\/10\u2010mg FDC compared with coadministration of the separate commercially available formulations in healthy adults under fed conditions. During each period, participants received either a single oral dose of D\/C\/F\/TAF 675\/150\/200\/10\u2010mg FDC (test) or a single oral dose of darunavir 600 and 75\u00a0mg, cobicistat 150\u00a0mg, and emtricitabine\/tenofovir alafenamide 200\/10\u2010mg FDC (reference). Thirty\u2010seven participants were randomly assigned to one of 2 treatment sequence groups: test\u2010reference\u2010reference\u2010test or reference\u2010test\u2010test\u2010reference, with 7\u00a0days or more washout between periods. The 90% confidence intervals of the geometric mean ratios for maximum plasma concentration, area under the concentration\u2013time curve from time zero to last measurable concentration, and area under the concentration\u2013time curve extrapolated to infinity for darunavir, cobicistat, emtricitabine, and tenofovir alafenamide fell within conventional bioequivalence limits (80%\u2013125%). No Grade 3\/4 adverse events, serious adverse events, or deaths occurred. In conclusion, administration of D\/C\/F\/TAF 675\/150\/200\/10\u2010mg FDC was bioequivalent to coadministration of the separate commercially available formulations.<\/jats:p>","DOI":"10.1002\/cpdd.1293","type":"journal-article","created":{"date-parts":[[2023,6,19]],"date-time":"2023-06-19T11:14:35Z","timestamp":1687173275000},"page":"1060-1068","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Bioequivalence of a Pediatric Fixed\u2010Dose Combination Tablet Darunavir\/Cobicistat\/Emtricitabine\/Tenofovir Alafenamide Compared With Coadministration of the Separate Agents in Healthy Adults: An Open\u2010Label, Randomized, Replicate Crossover Study"],"prefix":"10.1002","volume":"12","author":[{"given":"Sandy","family":"Van Hemelryck","sequence":"first","affiliation":[{"name":"Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erika","family":"Van Landuyt","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jay","family":"Ariyawansa","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simon","family":"Vanveggel","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martyn","family":"Palmer","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; 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