{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:04:16Z","timestamp":1787015056978,"version":"build-2736575974"},"reference-count":30,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2011,8,18]],"date-time":"2011-08-18T00:00:00Z","timestamp":1313625600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Basic Clin Pharma Tox"],"published-print":{"date-parts":[[2012,2]]},"abstract":"<jats:p>\n                    <jats:bold>Abstract:\u2002<\/jats:bold>\n                    Recombinant human parathyroid hormone [rhPTH(1\u201384)] represents a new class of anabolic agents for the treatment of osteoporosis. The present study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of rhPTH(1\u201384) after single\u2010 and multiple\u2010dose subcutaneous administration in healthy Chinese volunteers. Six cohorts of 32 volunteers received a single dose of rhPTH(1\u201384) at 0.5\u20135.0\u2003\u03bcg\/kg, and two cohorts of 12 volunteers received 2.0 and 3.0\u2003\u03bcg\/kg of rhPTH(1\u201384) once daily for 7 consecutive days to assess its safety and tolerability. The results indicated that rhPTH(1\u201384) appeared to be safe and well tolerated. Additionally, pharmacokinetics of rhPTH(1\u201384) and its active N\u2010terminal fragment rhPTH(1\u201334) were investigated after administration of single 1.0, 2.0 and 4.0\u2003\u03bcg\/kg doses of rhPTH(1\u201384) in 30 other volunteers and after multiple doses of 2.0\u2003\u03bcg\/kg once daily for 7 consecutive days. The pharmacokinetic parameters for rhPTH(1\u201384) and rhPTH(1\u201334) after subcutaneous administration of a single dose of 1.0, 2.0 and 4.0\u2003\u03bcg\/kg were as follows:\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    \u2003=\u2003(110.54\u2003\u00b1\u200359.18), (149.70\u2003\u00b1\u200350.61) and (372.52\u2003\u00b1\u200394.96)\u2003pg\/mL; (53.93\u2003\u00b1\u20036.27), (61.12\u2003\u00b1\u200311.28) and (89.04\u2003\u00b1\u20037.08)\u2003pg\/mL, respectively. AUC\n                    <jats:sub>0\u201310\u2003<\/jats:sub>\n                    =\n                    <jats:sub>\u2003<\/jats:sub>\n                    (268.87\u2003\u00b1\u200347.72), (538.93\u2003\u00b1\u2003146.89) and (1364.11\u2003\u00b1\u2003176.82)\u2003pg\u2003hr\/mL; (197.20\u2003\u00b1\u200350.78), (207.15\u2003\u00b1\u200372.08) and (344.05\u2003\u00b1\u200377.06)\u2003pg\u2003hr\/mL, respectively.\n                    <jats:italic>t<\/jats:italic>\n                    <jats:sub>1\/2\u2003<\/jats:sub>\n                    =\n                    <jats:sub>\u2003<\/jats:sub>\n                    (2.34\u2003\u00b1\u20031.93), (2.58\u2003\u00b1\u20031.18) and (2.74\u2003\u00b1\u20031.31)\u2003hr; (3.37\u2003\u00b1\u20031.82), (4.39\u2003\u00b1\u20033.79), and (3.99\u2003\u00b1\u20031.85) hr, respectively. Plasma\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    and AUC values of rhPTH(1\u201384) and rhPTH(1\u201334) were found to be dose proportional. The pharmacokinetic parameters for rhPTH(1\u201384) and rhPTH(1\u201334) after administration of multiple doses of 2.0\u2003\u03bcg\/kg were as follows:\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>ss_max<\/jats:sub>\n                    \u2003=\u2003(164.96\u2003\u00b1\u200352.61) and (75.05\u2003\u00b1\u20037.31)\u2003pg\/mL;\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>ss_min<\/jats:sub>\n                    \u2003=\u2003(6.99\u2003\u00b1\u20037.73) and (2.05\u2003\u00b1\u20032.82) pg\/mL; AUC\n                    <jats:sub>ss<\/jats:sub>\n                    \u2003=\u2003(567.26\u2003\u00b1\u2003118.41) and (306.02\u2003\u00b1\u200377.55) pg\u2003hr\/mL;\n                    <jats:italic>t<\/jats:italic>\n                    <jats:sub>1\/2\u2003<\/jats:sub>\n                    =\n                    <jats:sub>\u2003<\/jats:sub>\n                    (1.81\u2003\u00b1\u20030.89) and (2.27\u2003\u00b1\u20031.11)\u2003hr; DF\u2003=\u2003(6.93\u2003\u00b1\u20032.64) and (6.00\u2003\u00b1\u20031.37), respectively. After multiple doses, the pharmacokinetic parameters for rhPTH(1\u201384) were consistent with those after single dose. However, the mean\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    and AUC\n                    <jats:sub>0\u201310<\/jats:sub>\n                    of rhPTH(1\u201334) after multiple dosing were significantly higher than the corresponding values obtained after single\u2010dose administration. Serum total calcium and phosphate concentrations increased and decreased significantly at 4\u2003hr post\u2010dosing, respectively.\n                  <\/jats:p>","DOI":"10.1111\/j.1742-7843.2011.00768.x","type":"journal-article","created":{"date-parts":[[2011,7,20]],"date-time":"2011-07-20T01:31:19Z","timestamp":1311125479000},"page":"154-161","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Recombinant Human Parathyroid Hormone after Single\u2010 and Multiple\u2010Dose Subcutaneous Administration in Healthy Chinese Volunteers"],"prefix":"10.1111","volume":"110","author":[{"given":"Yani","family":"Liu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaojun","family":"Shi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianhong","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhongfang","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xingqin","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fandian","family":"Zeng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2011,8,18]]},"reference":[{"key":"e_1_2_9_2_2","unstructured":"National Institutes of Health (NIH).The NIH Osteoporosis and Related Bone Diseases \u2013 National Resource Center. Osteoporosis.http:\/\/www.niams.nih.gov\/health_Info\/Bone\/Osteoporosis\/default.asp(last accessed on 1 September 2010)."},{"key":"e_1_2_9_3_2","doi-asserted-by":"publisher","DOI":"10.1038\/ncpendmet0941"},{"key":"e_1_2_9_4_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11914-008-0005-9"},{"key":"e_1_2_9_5_2","doi-asserted-by":"publisher","DOI":"10.1590\/S0004-27302010000200018"},{"key":"e_1_2_9_6_2","doi-asserted-by":"publisher","DOI":"10.4158\/EP.10.2.139"},{"key":"e_1_2_9_7_2","doi-asserted-by":"publisher","DOI":"10.2147\/ciia.2007.2.1.163"},{"key":"e_1_2_9_8_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-146-5-200703060-00005"},{"key":"e_1_2_9_9_2","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.68.1.63"},{"key":"e_1_2_9_10_2","doi-asserted-by":"publisher","DOI":"10.1210\/er.2004-0006"},{"key":"e_1_2_9_11_2","doi-asserted-by":"publisher","DOI":"10.1210\/er.2003-0024"},{"key":"e_1_2_9_12_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1G146"},{"key":"e_1_2_9_13_2","first-page":"869","article-title":"Pharmacokinetics and safety of recombinant human parathyroid hormone (1\u201334) (teriparatide) after single ascending doses in Chinese healthy volunteers","volume":"62","author":"Chu NN","year":"2007","journal-title":"Pharmazie"},{"key":"e_1_2_9_14_2","doi-asserted-by":"publisher","DOI":"10.1042\/cs0680171"},{"key":"e_1_2_9_15_2","doi-asserted-by":"publisher","DOI":"10.1210\/jc.80.1.60"},{"key":"e_1_2_9_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1098-2825(1998)12:5<268::AID-JCLA3>3.0.CO;2-2"},{"key":"e_1_2_9_17_2","doi-asserted-by":"publisher","DOI":"10.1210\/jc.77.6.1535"},{"key":"e_1_2_9_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijpharm.2006.03.005"},{"key":"e_1_2_9_19_2","doi-asserted-by":"publisher","DOI":"10.1002\/jps.20720"},{"key":"e_1_2_9_20_2","unstructured":"FORTEO (teriparatide [rDNA origin] injection for Subcutaneous use) [package insert]. Product information.http:\/\/www.rxlist.com\/forteo\u2010drug.htm(last accessed on 19 August 2010)."},{"key":"e_1_2_9_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0009-9236(97)90169-7"},{"key":"e_1_2_9_22_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11596-009-0408-6"},{"key":"e_1_2_9_23_2","unstructured":"State Food and Drug Administration.Good clinical practice guideline.http:\/\/www.sda.gov.cn\/WS01\/CL0053\/24473.html(last accessed on 30 October 2010)."},{"key":"e_1_2_9_24_2","unstructured":"European Medicines Agency. ICH Topic E 6 (R1):Guideline for Good Clinical Practice. Note for guidance on good clinical practice.http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2009\/09\/WC500002874.pdf(last accessed on 30 October 2010)."},{"key":"e_1_2_9_25_2","unstructured":"World Medical Association Declaration of Helsinki \u2013 ethical principles for medical research involving human subjects.http:\/\/www.wma.net\/en\/30publications\/10policies\/b3\/index.html(last accessed on 30 October 2010)."},{"key":"e_1_2_9_26_2","doi-asserted-by":"publisher","DOI":"10.1210\/jcem.86.3.7366"},{"key":"e_1_2_9_27_2","doi-asserted-by":"publisher","DOI":"10.1023\/A:1026522619828"},{"key":"e_1_2_9_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(04)90128-2"},{"key":"e_1_2_9_29_2","doi-asserted-by":"publisher","DOI":"10.1210\/endo.142.2.7955"},{"key":"e_1_2_9_30_2","doi-asserted-by":"publisher","DOI":"10.1002\/jbmr.5650090403"},{"key":"e_1_2_9_31_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-7843.2004.pto940602.x"}],"container-title":["Basic &amp; Clinical Pharmacology &amp; Toxicology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fj.1742-7843.2011.00768.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1742-7843.2011.00768.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,15]],"date-time":"2023-10-15T09:10:22Z","timestamp":1697361022000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1742-7843.2011.00768.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,8,18]]},"references-count":30,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2012,2]]}},"alternative-id":["10.1111\/j.1742-7843.2011.00768.x"],"URL":"https:\/\/doi.org\/10.1111\/j.1742-7843.2011.00768.x","archive":["Portico"],"relation":{},"ISSN":["1742-7835","1742-7843"],"issn-type":[{"value":"1742-7835","type":"print"},{"value":"1742-7843","type":"electronic"}],"subject":[],"published":{"date-parts":[[2011,8,18]]},"assertion":[{"value":"2011-08-18","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}