{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,25]],"date-time":"2026-04-25T03:40:52Z","timestamp":1777088452170,"version":"3.51.4"},"reference-count":18,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T00:00:00Z","timestamp":1774915200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T00:00:00Z","timestamp":1774915200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Elagolix is a short\u2010acting oral gonadotropin\u2010releasing hormone antagonist utilized for treating endometriosis\u2010associated pain by rapidly suppressing gonadotropins and estradiol. Although well characterized in Western populations, clinical data regarding its use in Indian women remain limited. This study evaluated the pharmacokinetics, safety, and bioequivalence of a test 200\u00a0mg Elagolix tablet against a reference formulation under fasting conditions. The randomized, open\u2010label, four\u2010period crossover trial involved 60 healthy women aged 18\u201040 years who received single oral doses of either formulation. Plasma concentrations were monitored via validated UHPLC\u2010MS\/MS for 24 h post\u2010dose. Fifty\u2010nine participants completed the study, with results indicating rapid absorption (median T\n                    <jats:sub>max<\/jats:sub>\n                    1.25\u20101.50 h) and a mean half\u2010life of approximately 2.1\u20102.2 h. Bioequivalence was established as the 90% confidence intervals for key pharmacokinetic parameters\u2014C\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                    \u2014fell within the regulatory 80%\u2010125% acceptance limits. Specifically, the median AUC\n                    <jats:sub>0\u2010t<\/jats:sub>\n                    was 3341.23\u00a0ng h\/mL for the test product compared to 3365.30\u00a0ng h\/mL for the reference. Both formulations exhibited comparable safety profiles, with only five mild, resolvable adverse events reported. These findings confirm that the test formulation is bioequivalent to the reference standard, supporting its viability as a safe and effective therapeutic alternative.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70053","type":"journal-article","created":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T03:01:47Z","timestamp":1775012507000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Single\u2010Dose Bioequivalence Study of Elagolix Tablets 200\u00a0mg (Test Product) and Elagolix Tablets 200\u00a0mg (Reference Product) in Healthy Non\u2010Pregnant, Non\u2010Lactating Premenopausal Female Subjects Under Fasting Conditions"],"prefix":"10.1002","volume":"15","author":[{"given":"Sudershan","family":"Kumar","sequence":"first","affiliation":[{"name":"Sun Pharmaceutical Industries Limited  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arshad","family":"Khuroo","sequence":"additional","affiliation":[{"name":"Sun Pharmaceutical Industries Limited  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reshma","family":"Quadros","sequence":"additional","affiliation":[{"name":"Sun Pharmaceutical Industries Limited  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shruti","family":"Dharmadhikari","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Limited  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chintan","family":"Khandhedia","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Limited  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gaurav","family":"Puppalwar","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Limited  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amey","family":"Mane","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Limited  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,3,31]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/aji.13590"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2024.9210"},{"key":"e_1_2_10_4_1","unstructured":"Endometriosis. Accessed December 19 2024.https:\/\/www.who.int\/news\u2010room\/fact\u2010sheets\/detail\/endometriosis"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0015-0282(02)03331-9"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/1933719117707054"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sxmr.2017.06.005"},{"key":"e_1_2_10_8_1","volume-title":"StatPearls","author":"Tsamantioti ES","year":"2024"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms24086992"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2017.01.013"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.5301\/je.5000157"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-019-00840-7"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2024.06.040"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/hropen\/hoac009"},{"issue":"8","key":"e_1_2_10_15_1","first-page":"502","article-title":"Elagolix (orilissa) for endometriosis pain","volume":"100","author":"Ford B","year":"2019","journal-title":"Am Fam Physician"},{"key":"e_1_2_10_16_1","unstructured":"Research C for DE and.Bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an abbreviated new drug application. Published August 20 2021. Accessed December 20 2024.https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/bioequivalence\u2010studies\u2010pharmacokinetic\u2010endpoints\u2010drugs\u2010submitted\u2010under\u2010abbreviated\u2010new\u2010drug."},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2016-3845"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2008-1695"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1700089"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70053","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70053","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70053","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,25]],"date-time":"2026-04-25T03:08:59Z","timestamp":1777086539000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70053"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,31]]},"references-count":18,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,4]]}},"alternative-id":["10.1002\/cpdd.70053"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70053","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,31]]},"assertion":[{"value":"2025-12-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-11","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-31","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70053"}}