Pharmacokinetic comparison of JLP-1401 and co-administration of telmisartan/amlodipine and rosuvastatin in healthy adult volunteers

[Speaker] Sun-Young Kim:1
[Co-author] Ji-Young Jeon:1, Seol Ju Moon:1, Yong Woo Lee:2, Eun Young Son:2, Jun Hong Park:2, Kyungho Jang:1, Min-Gul Kim:1,3
1:Biomedical Research Institute, Chonbuk National University Hospital, Center for Clinical Pharmacology, Korea, 2:Jeil Pharmaceutical Co, Ltd, Korea, 3:Department of Pharmacology, School of Medicine, Chonbuk National University, Jeonju, Korea

BACKGROUND: Combination therapy telmisartan/amlodipine and rosuvastatin provides effective blood pressure control and vascular protection. This study aimed to compare the pharmacokinetics of JLP-1401 (telmisartan/amlodipine/rosuvastatin fixed-dose combination) with concomitant administration of telmisartan/amlodipine and rosuvastatin in healthy adult volunteers.
METHODS: This study was designed as a randomized, open-label, single dose, 4-period replicate crossover study in healthy adult subjects. A total of 40 subjects were randomly assigned to 1 of 2 sequences and received either the reference (telmisartan 80 mg/amlodipine 10 mg and rosuvastatin 20 mg) or the test drug JLP-1401 (telmisartan 80 mg/amlodipine 10 mg/rosuvastatin 20 mg fixed-dose combination) in each period. Blood samples were collected at intervals over 72 hours of telmisartan and amlodipine, and 48 hours of rosuvastatin. Between treatment periods, there was a 14-day washout. Safety assessments were performed.
RESULTS: Thirty-one subjects completed the study and were included in the pharmacokinetic analysis. The within-subject CV for Cmax of telmisartan was 46.86% and the acceptance range was 0.7128-1.4030. The geometric mean ratios (test/reference) and 90% confidence intervals of AUClast and Cmax for telmisartan, amlodipine and rosuvastatin were all within acceptance range. There was no serious adverse event and all reported adverse events were mild or moderate.
CONCLUSION: This study demonstrated that a JLP-1401 (telmisartan 80 mg/amlodipine 10 mg/rosuvastatin 20 mg fixed-dose combination) is bioequivalent to co-administration of reference drugs. Both formulations were safe and well tolerated, and no significant difference was observed in the safety assessments of the treatments.

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