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Pharmacokinetic Interaction Between Amlodipine and Lobeglitazone, a Novel Peroxisome Proliferator–activated Receptor-γ Agonist, in Healthy Subjects

Authors
 Kim Choon OK  ;  Sil Oh Eun  ;  Park Min Soo  ;  Kim Chin 
Citation
 Clinical Therapeutics, Vol.37(9) : 1999-2006, 2015 
Journal Title
 Clinical Therapeutics 
ISSN
 0149-2918 
Issue Date
2015
MeSH
Adult ; Amlodipine/administration & dosage ; Amlodipine/blood ; Amlodipine/pharmacokinetics* ; Antihypertensive Agents/administration & dosage ; Antihypertensive Agents/blood ; Antihypertensive Agents/pharmacokinetics* ; Area Under Curve ; Asian Continental Ancestry Group ; Cross-Over Studies ; Drug Interactions ; Healthy Volunteers ; Humans ; Hypoglycemic Agents/administration & dosage ; Hypoglycemic Agents/blood ; Hypoglycemic Agents/pharmacokinetics* ; Male ; PPAR gamma/agonists ; Pyrimidines/administration & dosage ; Pyrimidines/blood ; Pyrimidines/pharmacokinetics* ; Republic of Korea ; Thiazolidinediones/administration & dosage ; Thiazolidinediones/blood ; Thiazolidinediones/pharmacokinetics* ; Young Adult
Keywords
amlodipine ; interaction ; lobeglitazone ; pharmacokinetics
Abstract
Purpose : Lobeglitazone, a peroxisome proliferator–activated receptor-γ agonist, was developed for the treatment of diabetes mellitus. Because the prevalence of hypertension is high among patients with diabetes mellitus, lobeglitazone is likely to be used with the antihypertensive drug amlodipine. We evaluated the pharmacokinetic interactions between lobeglitazone and amlodipine in healthy male Korean subjects. Methods : The study used a randomized, open-label, multiple-dose, 3-treatment, 3-period, 6-sequence crossover design. A total of 24 healthy subjects were enrolled. Blood samples for pharmacokinetic analysis were collected according to a planned schedule after 0.5 mg of lobeglitazone and 10 mg of amlodipine were administered alone or concomitantly once per day for 10 days. Findings : A total of 24 healthy male subjects participated in the study (mean [SD] age, 26.6 [3.9] years; weight, 67.8 [5.7] kg; and height, 173.6 [6.4] cm). Three participants voluntarily withdrew after the second period, and 1 participant dropped out because of increased creatinine kinase levels caused by strenuous exercise before the start of the third period. Thus, 21 participants completed the study schedule to compare the pharmacokinetic parameters of lobeglitazone, and 22 participants completed the study of amlodipine. The geometric mean ratio (with 90% CIs) of Cmax,ss and AUCτ,ss for lobeglitazone administered concomitantly with amlodipine versus lobeglitazone administered alone was 1.01 (0.93–1.09) and 1.06 (0.92–1.23), respectively. The geometric mean ratio (with 90% CIs) of Cmax,ss and AUCτ,ss for amlodipine administered concomitantly with lobeglitazone versus amlodipine administered alone was 0.98 (0.94–1.02) and 1.00 (0.96–1.05). No serious drug-induced adverse events were reported in the study, and no clinically significant changes in vital signs, physical examination results, clinical laboratory results, or ECGs were noted.
Full Text
http://www.sciencedirect.com/science/article/pii/S0149291815008723
DOI
10.1016/j.clinthera.2015.06.009
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Choon Ok(김춘옥) ORCID logo https://orcid.org/0000-0002-2319-1108
Park, Min Soo(박민수) ORCID logo https://orcid.org/0000-0002-4395-9938
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/141822
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