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Effect of food on the oral bioavailability of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide fixed dose combination tablets in healthy subjects
Author(s) -
Sunkara Gangadhar,
Jiang Xuemin,
Reynolds Christine,
Serra Denise,
Zhang Yiming,
LiguerosSaylan Monica,
Ayalasomayajula Surya,
Winter Serge,
Jarugula Venkateswar
Publication year - 2014
Publication title -
clinical pharmacology in drug development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.711
H-Index - 22
eISSN - 2160-7648
pISSN - 2160-763X
DOI - 10.1002/cpdd.131
Subject(s) - valsartan , amlodipine , medicine , pharmacology , hydrochlorothiazide , cmax , bioavailability , pharmacokinetics , fixed dose combination , crossover study , blood pressure , placebo , alternative medicine , pathology
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‐to‐severe 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 mg) and amlodipine/valsartan/HCTZ (10/320/25 mg 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‐compartmental analysis. Following amlodipine/valsartan administration, the geometric mean ratios (GMRs, 90% CI) of AUC 0–∞ and Cmax were 1.09 (1.05–1.13) and 1.03 (0.97–1.09) for amlodipine, and 0.94 (0.81–1.10) and 0.86 (0.73–1.02) for valsartan, respectively. Following amlodipine/valsartan/HCTZ administration, the GMRs (90%CI) of AUC 0‐∞ and Cmax were 1.09 (1.04–1.15) and 1.11 (1.05–1.08) for amlodipine, 1.14 (0.99–1.31) and 1.12 (0.98–1.29) for valsartan, and 1.09 (1.02–1.16) and 0.86 (0.79–0.93) 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.