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CONCLUSION

A population pharmacokinetic-pharmacodynamic analysis to assess food effect on PK and PD of fimasartan in healthy male subjects. Jongtae Lee, Sangil Jeon, Seunghoon Han, Dong-Seok Yim

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CONCLUSION

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  1. A population pharmacokinetic-pharmacodynamic analysis to assess food effect on PK and PD of fimasartan in healthy male subjects Jongtae Lee, Sangil Jeon, Seunghoon Han, Dong-Seok Yim Department of Clinical Pharmacology and Therapeutics, SeoulSt. Mary’s Hospital, Seoul, Korea; Department of Pharmacology, College of Medicine, the Catholic University of Korea, Seoul, Korea BACKGROUND & OBJECTIVE Fimasartan is a novel non-peptide angiotensin II receptor antagonist which selectively blocks the AT1 receptor. A clinical trial was performed in healthy subjects to assess the effect of food on the PK of fimasartan. To explore the exposure-response relationship and the influence of food intake on it, a PK-PD model was developed. METHODS A randomized crossover trial of 240 mg tablet of fimasartan was performed in 24 healthy volunteers to evaluate the food effect. Extensive PK sampling was done (at 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12 and 24 h after dose) as well as systolic and diastolic blood pressure measurements at 0, 4, 8, 12 and 24 h. The results were analyzed using mixed effect methods NONMEM (Ver.6.2). RESULTS DEMOGRAPHICS PK-PD MODEL BASIC GOODNESS-OF-FIT PLOT OF PK FINAL PK PARAMETER ESTIMATES VISUAL PREDICTIVE CHECK OF PK MODEL FINAL PD PARAMETER ESTIMATES BASIC GOODNESS-OF-FIT PLOT OF PD VISUAL PREDICTIVE CHECK OF PD MODEL SBP DBP CONCLUSION Because of the alteration of PK property in absorption phase, different PK models were used to characterize the food effect. However, the final PK-PD model demonstrated that PK changes by the food had little effect on blood pressure.

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