{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T19:50:02Z","timestamp":1780429802615,"version":"3.54.1"},"reference-count":35,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T00:00:00Z","timestamp":1770249600000},"content-version":"vor","delay-in-days":4,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"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":[[2026,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    The growing demand for assisted reproductive technology (ART) has increased the need for effective luteal phase support. Progesterone, essential for maintaining early pregnancy, is a critical component of ART. This open\u2010label, balanced, randomized, two\u2010treatment, crossover, single\u2010dose study compared the bioequivalence of aqueous progesterone 25\u00a0mg injection (AqSusten\n                    <jats:sup>\u00ae<\/jats:sup>\n                    [Test, Sun Pharma Laboratories Limited]), compared to the innovator's aqueous progesterone 25\u00a0mg injection (Lubion\n                    <jats:sup>\u00ae<\/jats:sup>\n                    [Reference, IBSA Farmaceutici Italia Srl]), in healthy postmenopausal women under fasting conditions. Forty\u2010eight subjects received either treatment in Period 1, followed by alternate treatment in Period 2, with a 14\u2010day washout period. Pharmacokinetics (\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2013t<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2010\u221e<\/jats:sub>\n                    ) and mean plasma concentration\u2013time profiles were assessed. Forty\u2010five subjects completed the study. Pharmacokinetic data for both products were comparable, with percentage ratios for AUC\n                    <jats:sub>0\u2013t<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2212\u221e<\/jats:sub>\n                    , and\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    of 99.16%, 98.78%, and 103.36%, respectively, within the acceptable bioequivalence range of 80%\u2010125%. Plasma concentration\u2013time profiles were similar, and no serious adverse events were reported. Mild adverse events with Lubion\n                    <jats:sup>\u00ae<\/jats:sup>\n                    included increased white blood cell count and blood glucose. AqSusten\n                    <jats:sup>\u00ae<\/jats:sup>\n                    demonstrated bioequivalence to Lubion\n                    <jats:sup>\u00ae<\/jats:sup>\n                    in healthy postmenopausal women under fasting conditions. Both formulations exhibited similar pharmacokinetic profiles, with favorable safety and tolerability, suggesting AqSusten\n                    <jats:sup>\u00ae<\/jats:sup>\n                    as a viable alternative in ART treatments.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70025","type":"journal-article","created":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T12:59:23Z","timestamp":1770296363000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A comparative pharmacokinetic evaluation of two aqueous progesterone 25\u00a0mg injections in healthy postmenopausal women under fasting conditions: An open\u2010label, balanced, randomized, two\u2010treatment, two\u2010period, two\u2010sequence, single\u2010dose, crossover bioequivalence study"],"prefix":"10.1002","volume":"15","author":[{"given":"Noopur","family":"Vyas","sequence":"first","affiliation":[{"name":"Sun Pharma Laboratories Ltd.  Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amaresh","family":"Chakra","sequence":"additional","affiliation":[{"name":"Sun Pharmaceutical Industries Ltd.  Vadodara India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prashant","family":"Sarode","sequence":"additional","affiliation":[{"name":"Sun Pharmaceutical Industries Ltd.  Vadodara India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shruti","family":"Dharmadhikari","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Ltd.  Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gaurav","family":"Puppalwar","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Ltd.  Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chintan","family":"Khandhedia","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Ltd.  Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amey","family":"Mane","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Ltd.  Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alpesh","family":"Goyani","sequence":"additional","affiliation":[{"name":"Sun Pharmaceutical Industries Ltd.  Vadodara India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajay Jaysingh","family":"Khopade","sequence":"additional","affiliation":[{"name":"Sun Pharmaceutical Industries Ltd.  Vadodara India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,2,5]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"Infertility. Accessed January 22 2025.https:\/\/www.who.int\/news\u2010room\/fact\u2010sheets\/detail\/infertility"},{"key":"e_1_2_11_3_1","unstructured":"1 in 6 people globally affected by infertility: WHO. Accessed January 22 2025.https:\/\/www.who.int\/news\/item\/04\u201004\u20102023\u20101\u2010in\u20106\u2010people\u2010globally\u2010affected\u2010by\u2010infertility"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cegh.2020.08.008"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(24)00550-6"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1155\/2012\/686253"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1530\/RAF-24-0079"},{"key":"e_1_2_11_8_1","unstructured":"Issues for consideration: assisted reproductive technology (regulation) bill 2021. Accessed January 22 2025.https:\/\/prsindia.org\/files\/bills_acts\/bills_parliament\/2020\/Issues%20for%20Consideration%20\u2010%20ART%20Bill %202021.pdf"},{"issue":"5","key":"e_1_2_11_9_1","first-page":"QC01","article-title":"Comparison of the pharmacokinetics, bioequivalence and safety of aqueous progesterone formulation administered as either intramuscular or subcutaneous injection versus oil\u2010based progesterone formulation administered as intramuscular injection: a randomised study","volume":"17","author":"Mehta S","year":"2023","journal-title":"J Clin Diagn Res"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/humupd\/dmm021"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.4103\/2230-8210.107834"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S4192"},{"issue":"6","key":"e_1_2_11_13_1","article-title":"Luteal phase support for assisted reproduction cycles","volume":"2011","author":"Linden M","year":"2011","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/GCO.0b013e32832952ab"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/humupd\/6.2.139"},{"key":"e_1_2_11_16_1","unstructured":"ISAR.Good clinical practice recommendations. 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