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Lack of pharmacokinetic interaction between muraglitazar, a novel dual PPAR α/γ agonist, and fenofibrate
Author(s) -
MosquedaGarcia R.,
Reitberg D.,
Munsick C.,
Darbenzio R.,
Nepal S.,
Reeves R.,
Swaminathan A.
Publication year - 2005
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2004.11.057
Subject(s) - mura , cmax , pharmacokinetics , fenofibrate , pharmacology , crossover study , chemistry , geometric mean , medicine , mathematics , statistics , alternative medicine , pathology , liquid crystal display , computer science , placebo , operating system
Background Muraglitazar (MURA) is a novel PPAR α/γ dual agonist (nonthiazolidinedione) that reduces glucose and lipid levels in patients with type 2 diabetes. Fenofibrate (FF) is a lipid‐lowering agent likely to be co‐administered with MURA in diabetic patients. We assessed the potential for pharmacokinetic (PK) interaction between MURA and FF. Methods In an open‐label, 3‐period, 3‐treatment, crossover study, 30 healthy subjects were randomized to sequences that included 7 days administration of MURA (10mg QD), FF (160mg QD), or MURA+FF (10mg/d+160mg/d). Steady state plasma concentrations versus time were used to derive MURA and FF PK profiles. Results Administration of MURA with FF was well tolerated with no serious adverse experiences. FF did not affect the PK of MURA: the geometric mean (%CV) Cmax for MURA was 1122 (24), and for MURA+FF, 1202(23) ng/mL. The geometric mean (%CV) AUC(TAU) for MURA was 6994 (25), and for MURA+FF, 7900 (25) ng·h/mL. MURA had no effect on the PK of FF: the geometric mean (%CV) Cmax for FF was 15112 (25), and for FF+MURA, 15418 (26) ng/mL. The geometric mean (%CV) AUC(TAU) for FF was 235115 (34), and for FF+MURA, 238147 (32) ng·h/mL. Conclusion There was no PK interaction between FF and MURA based on Cmax and AUC (TAU) under the conditions of this study. Clinical Pharmacology & Therapeutics (2005) 77 , P14–P14; doi: 10.1016/j.clpt.2004.11.057