{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T05:06:57Z","timestamp":1790917617389,"version":"4.1.0"},"reference-count":26,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2011,6,1]]},"abstract":"<jats:p>This randomized, open-label study of patients in India with visceral leishmaniasis (VL) investigated the effect of food on sitamaquine and desethyl-sitamaquine pharmacokinetics. Patients were randomized to receive oral sitamaquine, 2 mg\/kg\/day, once a day for 21 days across four cohorts (n = 41) (fasted\/fed, fed\/fasted, fed\/fed, and fasted\/fasted) over two periods (days 1\u221210 and 11\u221221), or intravenous amphotericin B (AmB), 1 mg\/kg every other day for 30 days (n = 20). Mean day 21 pharmacokinetics across the four cohorts were sitamaquine, area under curve (AUC)<jats:sub>(0\u2212\u03c4)<\/jats:sub> = 6,627\u22128,903 ng.hr\/mL, AUC<jats:sub>(0\u221216)<\/jats:sub> = 4,859\u22126,633 ng.hr\/mL, maximum plasma concentration (<jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>) = 401\u2212570 ng\/mL, apparent terminal half-life (<jats:italic>t<\/jats:italic><jats:sub>1\/2<\/jats:sub>) = 18.3\u221222.8 hr, time to reach <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> (<jats:italic>t<\/jats:italic><jats:sub>max<\/jats:sub>) = 3.5\u22126 hr; and desethyl-sitamaquine, AUC<jats:sub>(0\u2212\u03c4)<\/jats:sub> = 2,307\u22123,163 ng.hr\/mL, <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> = 109\u2212154 ng\/mL, <jats:italic>t<\/jats:italic><jats:sub>1\/2<\/jats:sub> = 23.0\u221227.9 hr, <jats:italic>t<\/jats:italic><jats:sub>max<\/jats:sub> = 2\u221210 hr, with no significant food effect. On-therapy adverse events were observed for sitamaquine in 4 (10%) of 41 patients and for AmB in 17 (85%) of 20 patients. The final clinical cure (day 180) was 85% (95% confidence interval = 70.8\u201394.4%) for sitamaquine and 95% (95% confidence interval = 75.1\u201399.9) for AmB. Sitamaquine can be taken regardless of food intake, was generally well tolerated, and showed potential efficacy in patients with visceral leishmaniasis.<\/jats:p>","DOI":"10.4269\/ajtmh.2011.10-0409","type":"journal-article","created":{"date-parts":[[2011,6,1]],"date-time":"2011-06-01T18:44:22Z","timestamp":1306953862000},"page":"892-900","source":"Crossref","is-referenced-by-count":27,"title":["Pharmacokinetics of Oral Sitamaquine Taken with or without Food and Safety and Efficacy for Treatment of Visceral Leishmaniais: A Randomized Study in Bihar, India"],"prefix":"10.4269","volume":"84","author":[{"given":"Shyam","family":"Sundar","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prabhat K.","family":"Sinha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan A.","family":"Dixon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renata","family":"Buckley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann K.","family":"Miller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khadeeja","family":"Mohamed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahir","family":"Al-Banna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"key":"R1","series-title":"Regional Strategic Framework for Elimination of Kala-azar from the South-East Asia Region (2005\u20132015)","author":"World Health Organization","year":"2005"},{"key":"R2","series-title":"Trop Med Int Health","first-page":"899","article-title":"Serious underreporting of visceral leishmaniasis through 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