Effects of Age, Sex, and Race on the Safety and Pharmacokinetics of Single and Multiple Doses of Azilsartan Medoxomil in Healthy Subjects
Autor: | Wencan Zhang, Robert E. Harrell, Aziz Karim, Caroline Dudkowski |
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Rok vydání: | 2015 |
Předmět: |
Adult
Male Angiotensin receptor Adolescent 030204 cardiovascular system & hematology Pharmacology 030226 pharmacology & pharmacy law.invention 03 medical and health sciences Young Adult 0302 clinical medicine Pharmacokinetics Randomized controlled trial law Azilsartan medicine Humans Pharmacology (medical) Single-Blind Method Dosing Azilsartan Medoxomil Original Research Article Aged Aged 80 and over Oxadiazoles business.industry Racial Groups Middle Aged Healthy Volunteers Clinical trial Tolerability Benzimidazoles Female business Angiotensin II Type 1 Receptor Blockers medicine.drug |
Zdroj: | Clinical Pharmacokinetics |
ISSN: | 1179-1926 |
Popis: | Background and Objective Azilsartan medoxomil (AZL-M) is an angiotensin II receptor blocker approved to treat hypertension. After oral dosing, AZL-M is quickly hydrolyzed to azilsartan (AZL). The aims of this study were to assess the effects of age, sex, and race on the pharmacokinetics of AZL-M in healthy subjects, as well as safety and tolerability. Methods Sixty-one healthy adults were enrolled in this phase I, single-blind, randomized placebo-controlled study (placebo control was for assessment of safety/tolerability only). Subjects were stratified by age (18–45 vs. 65–85 years), sex, and race (black vs. white) and given oral AZL-M 60 mg (3 × 20 mg capsules) or placebo as a single dose (Day 1) and consecutive daily doses (Days 4–8) (6:2 ratio for AZL-M:placebo per group). Pharmacokinetics were evaluated (AZL-M patients only) on Days 1–3 and 8–9 and safety/tolerability was monitored. Results Age, sex, and race had no clinically meaningful effect on AZL exposures after single or multiple dosing. Pharmacokinetic parameters remained similar between Days 1 and 8 for each age, sex, and race subgroup. The frequency of adverse events was similar for AZL-M (32 %) and placebo (29 %). No discontinuations or serious adverse events occurred. Conclusions Based on these pharmacokinetic and safety/tolerability findings, no AZL-M dose adjustments are required based on age, sex, or race (black/white). |
Databáze: | OpenAIRE |
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