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To support clinical development in China, an open\u2010label, single\u2010center phase 1 study was conducted to evaluate the pharmacokinetics, safety, and tolerability of GLE\/PIB in healthy Chinese adults in Mainland China. Eighteen participants received 3 tablets of coformulated GLE\/PIB 100\/40\u00a0mg once daily (QD) for 7 days. Following GLE\/PIB 300\u00a0mg\/120\u00a0mg administration, GLE and PIB reached maximum concentration in 4\u20105 hours with a terminal elimination half\u2010life of 5.9 and 25 hours, respectively. Both GLE and PIB reached steady state by day 5, with no\u2010to\u2010minimal accumulation (\u226417% higher). GLE\/PIB exposures in healthy Chinese participants were similar to historical observations across phase 1 studies in healthy Western participants. GLE\/PIB was safe and well\u2010tolerated, with most adverse events being mild. These pharmacokinetics and safety data, together with existing global efficacy and safety data in healthy and HCV\u2010infected Western participants, support the use of GLE\/PIB 300\u00a0mg\/120\u00a0mg QD in adult Chinese patients with chronic HCV infection.<\/jats:p>","DOI":"10.1002\/cpdd.1325","type":"journal-article","created":{"date-parts":[[2023,9,4]],"date-time":"2023-09-04T07:25:56Z","timestamp":1693812356000},"page":"945-955","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics, Tolerability, and Safety of Glecaprevir\/Pibrentasvir Co\u2010formulated Bilayer Tablet Following Repeated Administration in Healthy Chinese Adults"],"prefix":"10.1002","volume":"12","author":[{"given":"Hari V.","family":"Kalluri","sequence":"first","affiliation":[{"name":"Clinical Pharmacology AbbVie Inc  North Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rajneet 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