Abstract

Objective: This study was conducted to compare the single-dose pharmacokinetic and safety profiles of JLP-1401 (fixed-dose combination (FDC) of telmisartan/amlodipine/rosuvastatin) to those of each constituent co-administered in healthy Korean male volunteers.
Materials and methods: A total of 40 healthy Korean subjects participated in an open-label, randomized, single-dose, 4-period crossover study. During each treatment period, the subjects received the test drug (FDC tablet of telmisartan/amlodipine/rosuvastatin 80 mg/10 mg/20 mg) or reference drug (co-administration of telmisartan/amlodipine FDC tablet and rosuvastatin tablet). Plasma samples were collected pre dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post dose to evaluate pharmacokinetic profiles. Safety was assessed by the evaluation of adverse events (AEs), laboratory assessments, 12-lead electrocardiograms, physical examinations, and vital sign measurements.
Results: The geometric least-square mean ratios and their 90% confidence intervals of AUC_last and C_max were 1.01 (0.94 – 1.07) and 0.83 (0.72 – 0.95) for telmisartan, 1.01 (0.99 – 1.04) and 1.03 (1.01 – 1.06) for amlodipine, and 1.03 (0.98 – 1.08) and 0.94 (0.85 – 1.04) for rosuvastatin, respectively. All AEs were of mild or moderate intensity, and there were no significant differences in the incidence of AEs between the treatments.
Discussion and conclusion: The pharmacokinetic profiles of the test and reference drugs were within the bioequivalent criteria, and both drugs were safe and well tolerated.


Author Details

Authors

• Seol Ju Moon^{1, 2, 3}
• Jeong-Soo Park¹
• Yong-Geun Kwak²
• Min-Gul Kim^{1, 2, 3}

Departments

• ¹ Center for Clinical Pharmacology and Biomedical Research Institute,
• ² Department of Pharmacology, School of Medicine, Jeonbuk National University, and
• ³ Research Institute of Clinical Medicine of Jeonbuk National University, Jeonju, South Korea

Address

Min-Gul Kim, MD, PhD
Center for Clinical Pharmacology and Biomedical Research Institute
Jeonbuk National University Hospital
20 Geonji-ro, Deokjin-gu, Jeonju-si,
Jeollabuk-do 54907, South Korea
Email: [email protected]

Citation