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Pharmacokinetic comparison of a fixed-dose combination versus concomitant administration of amlodipine, olmesartan, and rosuvastatin in healthy adult subjects.
Drug Des Devel Ther. 2019; 13:991-997.DD

Abstract

Objective:

The aim of this study was to compare the pharmacokinetic (PK) and safety profiles of a fixed dose combination (FDC) formulation and co-administration of amlodipine, olmesartan, and rosuvastatin. Materials and methods: This study was an open-label, randomized, cross-over design conducted in healthy male volunteers. All subjects received either a single FDC tablet containing amlodipine 10 mg/olmesartan 40 mg/rosuvastatin 20 mg, or were co-administered an FDC tablet containing amlodipine 10 mg/olmesartan 40 mg and a tablet containing rosuvastatin 20 mg, for each period, with 14-day washout periods. Plasma concentrations of amlodipine, olmesartan, and rosuvastatin were measured by liquid chromatography tandem mass spectrometry. Safety was evaluated by measuring vital signs, clinical laboratory parameters, physical examinations, and medical interviews.

Results:

Sixty-four subjects were enrolled, and 54 completed the study. The geometric mean ratios and 90% CI for the maximum plasma concentration (Cmax) and area under the curve from time zero to the last sampling time (AUCt) were 1.0716 (1.0369,1.1074) and 1.0497 (1.0243,1.0757) for amlodipine, 1.0396 (0.9818,1.1009) and 1.0138 (0.9716,1.0578) for olmesartan, and 1.0257 (0.9433,1.1152) and 1.0043 (0.9453,1.0669) for rosuvastatin. Fourteen cases of adverse events occurred in 12 subjects. There was no statistically significant clinical difference between the formulation groups.

Conclusion:

The 90% CI of the primary PK parameters were within the acceptance bioequivalence criteria, which is ln (0.8) and ln (1.25). These results indicate that the FDC formulation and co-administration of amlodipine, olmesartan and rosuvastatin are pharmacokinetically bioequivalent and have similar safety profiles.

Authors+Show Affiliations

Department of Pharmacology and PharmacoGenomics Research Center, Inje University College of Medicine, Busan, Republic of Korea.Department of Pharmacology and PharmacoGenomics Research Center, Inje University College of Medicine, Busan, Republic of Korea. Department of Clinical Pharmacology, Inje University Busan Paik Hospital, Busan, Republic of Korea.Department of Pharmacology and PharmacoGenomics Research Center, Inje University College of Medicine, Busan, Republic of Korea.Formulation Research Team, Daewoong Pharma, Seoul, Republic of Korea.Formulation Research Team, Daewoong Pharma, Seoul, Republic of Korea.Clinical Research Team, Daewoong Pharma, Seoul, Republic of Korea.Clinical Research Team, Daewoong Pharma, Seoul, Republic of Korea.Department of Pharmacology and PharmacoGenomics Research Center, Inje University College of Medicine, Busan, Republic of Korea. Department of Clinical Pharmacology, Inje University Busan Paik Hospital, Busan, Republic of Korea.

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

31114155

Citation

Oh, Minkyung, et al. "Pharmacokinetic Comparison of a Fixed-dose Combination Versus Concomitant Administration of Amlodipine, Olmesartan, and Rosuvastatin in Healthy Adult Subjects." Drug Design, Development and Therapy, vol. 13, 2019, pp. 991-997.
Oh M, Shin JG, Ahn S, et al. Pharmacokinetic comparison of a fixed-dose combination versus concomitant administration of amlodipine, olmesartan, and rosuvastatin in healthy adult subjects. Drug Des Devel Ther. 2019;13:991-997.
Oh, M., Shin, J. G., Ahn, S., Kim, B. H., Kim, J. Y., Shin, H. J., Shin, H. J., & Ghim, J. L. (2019). Pharmacokinetic comparison of a fixed-dose combination versus concomitant administration of amlodipine, olmesartan, and rosuvastatin in healthy adult subjects. Drug Design, Development and Therapy, 13, 991-997. https://doi.org/10.2147/DDDT.S202730
Oh M, et al. Pharmacokinetic Comparison of a Fixed-dose Combination Versus Concomitant Administration of Amlodipine, Olmesartan, and Rosuvastatin in Healthy Adult Subjects. Drug Des Devel Ther. 2019;13:991-997. PubMed PMID: 31114155.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacokinetic comparison of a fixed-dose combination versus concomitant administration of amlodipine, olmesartan, and rosuvastatin in healthy adult subjects. AU - Oh,Minkyung, AU - Shin,Jae-Gook, AU - Ahn,Sangzin, AU - Kim,Bo Hoon, AU - Kim,Ji Yeon, AU - Shin,Hyun Ju, AU - Shin,Hyun Ju, AU - Ghim,Jong-Lyul, Y1 - 2019/04/03/ PY - 2019/01/23/received PY - 2019/03/06/accepted PY - 2019/5/23/entrez PY - 2019/5/23/pubmed PY - 2019/12/24/medline KW - amlodipine KW - fixed-dose combination KW - olmesartan KW - pharmacokinetics KW - rosuvastatin SP - 991 EP - 997 JF - Drug design, development and therapy JO - Drug Des Devel Ther VL - 13 N2 - Objective: The aim of this study was to compare the pharmacokinetic (PK) and safety profiles of a fixed dose combination (FDC) formulation and co-administration of amlodipine, olmesartan, and rosuvastatin. Materials and methods: This study was an open-label, randomized, cross-over design conducted in healthy male volunteers. All subjects received either a single FDC tablet containing amlodipine 10 mg/olmesartan 40 mg/rosuvastatin 20 mg, or were co-administered an FDC tablet containing amlodipine 10 mg/olmesartan 40 mg and a tablet containing rosuvastatin 20 mg, for each period, with 14-day washout periods. Plasma concentrations of amlodipine, olmesartan, and rosuvastatin were measured by liquid chromatography tandem mass spectrometry. Safety was evaluated by measuring vital signs, clinical laboratory parameters, physical examinations, and medical interviews. Results: Sixty-four subjects were enrolled, and 54 completed the study. The geometric mean ratios and 90% CI for the maximum plasma concentration (Cmax) and area under the curve from time zero to the last sampling time (AUCt) were 1.0716 (1.0369,1.1074) and 1.0497 (1.0243,1.0757) for amlodipine, 1.0396 (0.9818,1.1009) and 1.0138 (0.9716,1.0578) for olmesartan, and 1.0257 (0.9433,1.1152) and 1.0043 (0.9453,1.0669) for rosuvastatin. Fourteen cases of adverse events occurred in 12 subjects. There was no statistically significant clinical difference between the formulation groups. Conclusion: The 90% CI of the primary PK parameters were within the acceptance bioequivalence criteria, which is ln (0.8) and ln (1.25). These results indicate that the FDC formulation and co-administration of amlodipine, olmesartan and rosuvastatin are pharmacokinetically bioequivalent and have similar safety profiles. SN - 1177-8881 UR - https://www.unboundmedicine.com/medline/citation/31114155/Pharmacokinetic_comparison_of_a_fixed_dose_combination_versus_concomitant_administration_of_amlodipine_olmesartan_and_rosuvastatin_in_healthy_adult_subjects_ L2 - https://dx.doi.org/10.2147/DDDT.S202730 DB - PRIME DP - Unbound Medicine ER -