{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,27]],"date-time":"2026-04-27T19:13:01Z","timestamp":1777317181444,"version":"3.51.4"},"reference-count":13,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2014,6,2]],"date-time":"2014-06-02T00:00:00Z","timestamp":1401667200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2014,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label\/><jats:p>A double fixed dose combination of amlodipine\/valsartan and triple fixed dose combination of amlodipine\/valsartan\/HCTZ tablets have been developed to treat patients with moderate\u2010to\u2010severe hypertension. Here, we present the effect of food on the oral bioavailability of these two fixed dose combination tablets from two separate clinical studies in healthy subjects. Single oral doses of amlodipine\/valsartan (10\/160\u2009mg) and amlodipine\/valsartan\/HCTZ (10\/320\/25\u2009mg were administered under fasted or fed conditions. Blood samples were collected in both studies to determine the pharmacokinetic parameters of amlodipine, valsartan, and\/or HCTZ using non\u2010compartmental analysis. Following amlodipine\/valsartan administration, the geometric mean ratios (GMRs, 90% CI) of AUC<jats:sub>0\u2013\u221e<\/jats:sub> and Cmax were 1.09 (1.05\u20131.13) and 1.03 (0.97\u20131.09) for amlodipine, and 0.94 (0.81\u20131.10) and 0.86 (0.73\u20131.02) for valsartan, respectively. Following amlodipine\/valsartan\/HCTZ administration, the GMRs (90%CI) of AUC<jats:sub>0\u2010\u221e<\/jats:sub> and Cmax were 1.09 (1.04\u20131.15) and 1.11 (1.05\u20131.08) for amlodipine, 1.14 (0.99\u20131.31) and 1.12 (0.98\u20131.29) for valsartan, and 1.09 (1.02\u20131.16) and 0.86 (0.79\u20130.93) for HCTZ, respectively. Considering the sample size and pharmacokinetic variability associated with analytes, these study results indicate that food effect is minimal or none when fixed dose combination tablets are administered with food. In conclusion, both fixed dose combination tablets can be administered without regards to meals.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cpdd.131","type":"journal-article","created":{"date-parts":[[2014,5,7]],"date-time":"2014-05-07T20:35:29Z","timestamp":1399494929000},"page":"487-492","source":"Crossref","is-referenced-by-count":14,"title":["Effect of food on the oral bioavailability of amlodipine\/valsartan and amlodipine\/valsartan\/hydrochlorothiazide fixed dose combination tablets in healthy subjects"],"prefix":"10.1002","volume":"3","author":[{"given":"Gangadhar","family":"Sunkara","sequence":"first","affiliation":[{"name":"Novartis Institute for Biomedical Research East Hanover NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xuemin","family":"Jiang","sequence":"additional","affiliation":[{"name":"Novartis Institute for Biomedical Research East Hanover NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christine","family":"Reynolds","sequence":"additional","affiliation":[{"name":"Novartis Institute for Biomedical Research East Hanover NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Denise","family":"Serra","sequence":"additional","affiliation":[{"name":"Novartis Institute for Biomedical Research East Hanover NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yiming","family":"Zhang","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation East Hanover NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Monica","family":"Ligueros\u2010Saylan","sequence":"additional","affiliation":[{"name":"Novartis Institute for Biomedical Research East Hanover NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Surya","family":"Ayalasomayajula","sequence":"additional","affiliation":[{"name":"Novartis Institute for Biomedical Research East Hanover NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Serge","family":"Winter","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals AG Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Venkateswar","family":"Jarugula","sequence":"additional","affiliation":[{"name":"Novartis Institute for Biomedical Research East Hanover NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,6,2]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.289.19.2560"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-199141030-00009"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-199754020-00009"},{"key":"e_1_2_6_5_1","first-page":"47","article-title":"Hydrochlorothiazide","volume":"16","author":"Meyer MC","year":"1976","journal-title":"J Am Pharm Assoc."},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehr177"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-197803050-00001"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1021\/mp0499407"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdd.647"},{"key":"e_1_2_6_10_1","first-page":"799","article-title":"Absorption of amlodipine unaffected by food. 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