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Pharmacokinetic and bioequivalence study comparing a candesartan cilexetil/rosuvastatin calcium fixed-dose combination with the concomitant administration of candesartan cilexetil and rosuvastatin calcium in healthy Korean subjects .
Int J Clin Pharmacol Ther. 2017 Mar; 55(3):286-294.IJ

Abstract

CONTEXT

A fixed-dose combination (FDC) of candesartan and rosuvastatin was recently developed for the treatment of cardiovascular disease and expected to enhance patient compliance.

OBJECTIVE

This study was performed to compare the single-dose pharmacokinetic properties and tolerability of DP-R208 (candesartan and rosuvastatin FDC) to those of each component administered alone in healthy Korean male volunteers.

MATERIALS AND METHODS

A total of 40 healthy Korean volunteers were enrolled in this randomized, open-label, single-dose, two-treatment, two-way crossover study. During each treatment period, subjects received the test formulation (FDC tablet containing candesartan and rosuvastatin) or reference formulation (co-administration of candesartan and rosuvastatin). Plasma samples were collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours post-dose. Safety and tolerability were assessed by the evaluation of adverse events (AEs), physical examinations, laboratory assessments, 12-lead electrocardiograms (ECGs), and vital sign measurements.

RESULTS

The 90% confidence intervals (CIs) of the geometric least-square mean ratios of Cmax, AUClast, and AUCinf were 0.86 - 1.00, 0.92 - 1.04, and 0.92 - 1.03 for candesartan, and 0.88 - 1.06, 0.91 - 1.08, and 0.91 - 1.03 for rosuvastatin, respectively. All of the AEs were mild, and there was no significant difference in the incidence of AEs between the formulations. Furthermore, the pharmacokinetic properties of the test and reference formulations met the regulatory criteria for bioequivalence. Discussion and conclusion: Both formulations were safe and well tolerated, and no significant difference was observed in the safety assessments of the treatments. .

Authors

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Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28079517

Citation

Park, Dan-Bee, et al. "Pharmacokinetic and Bioequivalence Study Comparing a Candesartan Cilexetil/rosuvastatin Calcium Fixed-dose Combination With the Concomitant Administration of Candesartan Cilexetil and Rosuvastatin Calcium in Healthy Korean Subjects ." International Journal of Clinical Pharmacology and Therapeutics, vol. 55, no. 3, 2017, pp. 286-294.
Park DB, Jang K, Lee JW, et al. Pharmacokinetic and bioequivalence study comparing a candesartan cilexetil/rosuvastatin calcium fixed-dose combination with the concomitant administration of candesartan cilexetil and rosuvastatin calcium in healthy Korean subjects . Int J Clin Pharmacol Ther. 2017;55(3):286-294.
Park, D. B., Jang, K., Lee, J. W., Park, C. W., Lee, B. H., Kim, M. G., & Jeon, J. Y. (2017). Pharmacokinetic and bioequivalence study comparing a candesartan cilexetil/rosuvastatin calcium fixed-dose combination with the concomitant administration of candesartan cilexetil and rosuvastatin calcium in healthy Korean subjects . International Journal of Clinical Pharmacology and Therapeutics, 55(3), 286-294. https://doi.org/10.5414/CP202740
Park DB, et al. Pharmacokinetic and Bioequivalence Study Comparing a Candesartan Cilexetil/rosuvastatin Calcium Fixed-dose Combination With the Concomitant Administration of Candesartan Cilexetil and Rosuvastatin Calcium in Healthy Korean Subjects. Int J Clin Pharmacol Ther. 2017;55(3):286-294. PubMed PMID: 28079517.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacokinetic and bioequivalence study comparing a candesartan cilexetil/rosuvastatin calcium fixed-dose combination with the concomitant administration of candesartan cilexetil and rosuvastatin calcium in healthy Korean subjects . AU - Park,Dan-Bee, AU - Jang,Kyungho, AU - Lee,Jae-Won, AU - Park,Cheol-Won, AU - Lee,Back-Hwan, AU - Kim,Min-Gul, AU - Jeon,Ji-Young, PY - 2017/02/14/accepted PY - 2017/1/13/pubmed PY - 2017/11/4/medline PY - 2017/1/13/entrez SP - 286 EP - 294 JF - International journal of clinical pharmacology and therapeutics JO - Int J Clin Pharmacol Ther VL - 55 IS - 3 N2 - CONTEXT: A fixed-dose combination (FDC) of candesartan and rosuvastatin was recently developed for the treatment of cardiovascular disease and expected to enhance patient compliance. OBJECTIVE: This study was performed to compare the single-dose pharmacokinetic properties and tolerability of DP-R208 (candesartan and rosuvastatin FDC) to those of each component administered alone in healthy Korean male volunteers. MATERIALS AND METHODS: A total of 40 healthy Korean volunteers were enrolled in this randomized, open-label, single-dose, two-treatment, two-way crossover study. During each treatment period, subjects received the test formulation (FDC tablet containing candesartan and rosuvastatin) or reference formulation (co-administration of candesartan and rosuvastatin). Plasma samples were collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours post-dose. Safety and tolerability were assessed by the evaluation of adverse events (AEs), physical examinations, laboratory assessments, 12-lead electrocardiograms (ECGs), and vital sign measurements. RESULTS: The 90% confidence intervals (CIs) of the geometric least-square mean ratios of Cmax, AUClast, and AUCinf were 0.86 - 1.00, 0.92 - 1.04, and 0.92 - 1.03 for candesartan, and 0.88 - 1.06, 0.91 - 1.08, and 0.91 - 1.03 for rosuvastatin, respectively. All of the AEs were mild, and there was no significant difference in the incidence of AEs between the formulations. Furthermore, the pharmacokinetic properties of the test and reference formulations met the regulatory criteria for bioequivalence. Discussion and conclusion: Both formulations were safe and well tolerated, and no significant difference was observed in the safety assessments of the treatments. . SN - 0946-1965 UR - https://www.unboundmedicine.com/medline/citation/28079517/Pharmacokinetic_and_bioequivalence_study_comparing_a_candesartan_cilexetil/rosuvastatin_calcium_fixed_dose_combination_with_the_concomitant_administration_of_candesartan_cilexetil_and_rosuvastatin_calcium_in_healthy_Korean_subjects__ L2 - https://www.dustri.com/nc/journals-in-english?artId=15094 DB - PRIME DP - Unbound Medicine ER -