Effect of food on the oral bioavailability of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide fixed dose combination tablets in healthy subjects

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 combinati...

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Bibliographic Details
Published in:Clinical pharmacology in drug development 2014-11, Vol.3 (6), p.487-492
Main Authors: Sunkara, Gangadhar, Jiang, Xuemin, Reynolds, Christine, Serra, Denise, Zhang, Yiming, Ligueros-Saylan, Monica, Ayalasomayajula, Surya, Winter, Serge, Jarugula, Venkateswar
Format: Article
Language:English
Subjects:
Administration, Oral
Adolescent
Adult
amlodipine
Amlodipine, Valsartan Drug Combination - administration & dosage
Amlodipine, Valsartan Drug Combination - adverse effects
Amlodipine, Valsartan Drug Combination - blood
Amlodipine, Valsartan Drug Combination - pharmacokinetics
Angiotensin II Type 1 Receptor Blockers - administration & dosage
Angiotensin II Type 1 Receptor Blockers - adverse effects
Angiotensin II Type 1 Receptor Blockers - blood
Angiotensin II Type 1 Receptor Blockers - pharmacokinetics
Antihypertensive Agents - administration & dosage
Antihypertensive Agents - adverse effects
Antihypertensive Agents - blood
Antihypertensive Agents - pharmacokinetics
Area Under Curve
Bioavailability
Biological Availability
Calcium Channel Blockers - administration & dosage
Calcium Channel Blockers - adverse effects
Calcium Channel Blockers - blood
Calcium Channel Blockers - pharmacokinetics
Cross-Over Studies
Dietary Fats - administration & dosage
Drug Combinations
Drug Monitoring
Female
fixed dose combination
Food
food effect
Food-Drug Interactions
Healthy Volunteers
Humans
Hydrochlorothiazide - administration & dosage
Hydrochlorothiazide - adverse effects
Hydrochlorothiazide - blood
Hydrochlorothiazide - pharmacokinetics
Male
Metabolic Clearance Rate
Middle Aged
Tablets
valsartan and hydrochlorothiazide (HCTZ)
Young Adult
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Summary: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 AUC0–∞ 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 AUC0‐∞ 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.
ISSN:2160-763X
2160-7648
DOI:10.1002/cpdd.131