NDLI: Pharmacokinetic Interaction Between Amlodipine and Lobeglitazone, a Novel Peroxisome Proliferator-activated Receptor-Î³ Agonist, in Healthy Subjects.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Kim, Choon Ok Sil Oh, Eun Kim, Chin Park, Min Soo
Spatial Coverage	Republic of Korea
Description	Author Affiliation: Kim CO ( Department of Clinical Pharmacology, Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea.); Sil Oh E ( Department of Clinical Pharmacology, Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea.); Kim C ( Chong Kun Dang Clinical Research and Clinical Epidemiology and Medical Information, CKD Pharmaceuticals, Seoul, Republic of Korea.); Park MS ( Department of Clinical Pharmacology, Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea)
Abstract	PURPOSE: Lobeglitazone, a peroxisome proliferator-activated receptor-Î³ 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. IMPLICATIONS: The coadministration of lobeglitazone and amlodipine did not affect the pharmacokinetics of lobeglitazone or amlodipine in these healthy male Korean subjects. ClinicalTrials.gov identifier: NCT01341392.
File Format	HTM / HTML
ISSN	01492918
Issue Number	9
Volume Number	37
e-ISSN	1879114X
Journal	Clinical Therapeutics
Language	English
Publisher	Elsevier
Publisher Date	2015-09-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Amlodipine Pharmacokinetics Antihypertensive Agents Hypoglycemic Agents Pyrimidines Thiazolidinediones Adult Administration & Dosage Blood Area Under Curve Asian Continental Ancestry Group Cross-over Studies Drug Interactions Healthy Volunteers Humans Male Ppar Gamma Agonists Republic Of Korea Young Adult Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Tolerability and pharmacokinetics of lobeglitazone, a novel peroxisome proliferator-activated receptor-Î³ agonist, after a single oral administration in healthy female subjects.

Tolerability and pharmacokinetics of lobeglitazone (CKD-501), a peroxisome proliferator-activated receptor-Î³ agonist: a single- and multiple-dose, double-blind, randomized control study in healthy male Korean subjects.

Assessment of the pharmacokinetics of co-administered metformin and lobeglitazone, a thiazolidinedione antihyperglycemic agent, in healthy subjects.

Effects of the peroxisome proliferator activated receptor-Î³ coactivator-1 (PGC-1 ) Thr394Thr and Gly482Ser polymorphisms on rosiglitazone response in Chinese patients with type 2 diabetes mellitus.

Pharmacokinetics of Mirabegron, a ß3-Adrenoceptor Agonist for Treatment of Overactive Bladder, in Healthy East Asian Subjects.

Lessons Learned after 25 Years of Studies on the Physiological Roles of the Peroxisome Proliferator-activated Receptor

Safety, Tolerability, and Pharmacokinetics of E3030, a Novel Peroxisome Proliferator-Activated Receptor α/γ Dual Agonist, in Healthy Japanese Male Subjects

Bioequivalence and comparison of pharmacokinetic properties of 4-mg tablet formulations of rosiglitazone hydrochloride and rosiglitazone maleate: a single-dose, randomized, open-label, two-period crossover study in healthy adult male Chinese volunteers.

Reversing vascular dysfunction in rheumatoid arthritis: improved augmentation index but not endothelial function with peroxisome proliferator-activated receptor Î³ agonist therapy.

Pharmacokinetic Interaction Between Amlodipine and Lobeglitazone, a Novel Peroxisome Proliferator-activated Receptor-Î³ Agonist, in Healthy Subjects.

Similar Documents

Tolerability and pharmacokinetics of lobeglitazone, a novel peroxisome proliferator-activated receptor-Î³ agonist, after a single oral administration in healthy female subjects.

Tolerability and pharmacokinetics of lobeglitazone (CKD-501), a peroxisome proliferator-activated receptor-Î³ agonist: a single- and multiple-dose, double-blind, randomized control study in healthy male Korean subjects.

Assessment of the pharmacokinetics of co-administered metformin and lobeglitazone, a thiazolidinedione antihyperglycemic agent, in healthy subjects.

Effects of the peroxisome proliferator activated receptor-Î³ coactivator-1 (PGC-1 ) Thr394Thr and Gly482Ser polymorphisms on rosiglitazone response in Chinese patients with type 2 diabetes mellitus.

Pharmacokinetics of Mirabegron, a ß3-Adrenoceptor Agonist for Treatment of Overactive Bladder, in Healthy East Asian Subjects.

Lessons Learned after 25 Years of Studies on the Physiological Roles of the Peroxisome Proliferator-activated Receptor

Safety, Tolerability, and Pharmacokinetics of E3030, a Novel Peroxisome Proliferator-Activated Receptor α/γ Dual Agonist, in Healthy Japanese Male Subjects

Bioequivalence and comparison of pharmacokinetic properties of 4-mg tablet formulations of rosiglitazone hydrochloride and rosiglitazone maleate: a single-dose, randomized, open-label, two-period crossover study in healthy adult male Chinese volunteers.

Reversing vascular dysfunction in rheumatoid arthritis: improved augmentation index but not endothelial function with peroxisome proliferator-activated receptor Î³ agonist therapy.

Pharmacokinetic Interaction Between Amlodipine and Lobeglitazone, a Novel Peroxisome Proliferator-activated Receptor-Î³ Agonist, in Healthy Subjects.