{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T07:17:13Z","timestamp":1788160633717,"version":"build-2803163510"},"reference-count":24,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T00:00:00Z","timestamp":1788134400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Cycloserine is a broad\u2010spectrum antibiotic and clinically important second\u2010line anti\u2010tuberculosis agent. This study assessed the bioequivalence of a test cycloserine formulation versus its reference formulation under fasted and fed conditions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Using a randomized, open\u2010label, two\u2010period, two\u2010sequence crossover design, 64 healthy Chinese participants were enrolled (63 completed). Subjects received a single 250\u2010mg oral dose of both formulations. Bioequivalence was evaluated using plasma concentration\u2010time profiles and key pharmacokinetic (PK) parameters. Statistical analysis employed the Average Bioequivalence (ABE) method. Geometric mean ratios (GMRs) and 90% confidence intervals (90% CIs) for C\n                      <jats:sub>max<\/jats:sub>\n                      , AUC\n                      <jats:sub>0\u2010t<\/jats:sub>\n                      and AUC\n                      <jats:sub>0\u2010\u221e<\/jats:sub>\n                      fell entirely within the predefined range (80.00\u2013125.00%) under both conditions.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Both formulations exhibited comparable safety profiles.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>Bioequivalence was established between the test and reference cycloserine capsules under fasted and fed states.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>\n                      Chinese Clinical Trial Registry (\n                      <jats:ext-link>www.chinadrugtrials.org.cn<\/jats:ext-link>\n                      ) as (CTR20233940).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fphar.2026.1801953","type":"journal-article","created":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T06:55:48Z","timestamp":1788159348000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics and safety comparison of cycloserine capsules and their generic counterpart: a randomized, open-label, two-period, two-sequence, single-dose crossover bioequivalence study in healthy Chinese subjects"],"prefix":"10.3389","volume":"17","author":[{"given":"Xiuqing","family":"Peng","sequence":"first","affiliation":[{"name":"Phase I Clinical Trial Laboratory; Hebei Key Laboratory of Clinical Pharmacy, Hebei General Hospital","place":["Shijiazhuang, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liying","family":"Zhang","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory; Hebei Key Laboratory of Clinical Pharmacy, Hebei General Hospital","place":["Shijiazhuang, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caiyun","family":"Jia","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory; Hebei Key Laboratory of Clinical Pharmacy, Hebei General Hospital","place":["Shijiazhuang, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Congyang","family":"Ding","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory; Hebei Key Laboratory of Clinical Pharmacy, Hebei General Hospital","place":["Shijiazhuang, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haojing","family":"Song","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory; Hebei Key Laboratory of Clinical Pharmacy, Hebei General Hospital","place":["Shijiazhuang, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhanjun","family":"Dong","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory; Hebei Key Laboratory of Clinical Pharmacy, Hebei General Hospital","place":["Shijiazhuang, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huizhen","family":"Wu","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory; Hebei Key Laboratory of Clinical Pharmacy, Hebei General Hospital","place":["Shijiazhuang, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wanjun","family":"Bai","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory; Hebei Key Laboratory of Clinical Pharmacy, Hebei General Hospital","place":["Shijiazhuang, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,8,31]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00055-19","article-title":"Cycloserine population pharmacokinetics and pharmacodynamics in patients with tuberculosis","volume":"63","author":"Alghamdi","year":"2019","journal-title":"Antimicrob. 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