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Pharmacokinetic and bioequivalence study of a fixed-dose combination of amlodipine besylate and rosuvastatin calcium compared to co-administration of separate tablets in healthy Korean subjects .
Int J Clin Pharmacol Ther. 2019 Dec; 57(12):612-622.IJ

Abstract

CONTEXT

A fixed-dose combination (FDC) tablet of amlodipine and rosuvastatin was recently developed for the treatment of concomitant hypertension and dyslipidemia and is anticipated to improve medication compliance.

OBJECTIVE

This study was performed to compare the single-dose pharmacokinetic properties and safety of DP-R212 (FDC of amlodipine and rosuvastatin) to those of each agent co-administered in healthy Korean subjects.

MATERIALS AND METHODS

A total of 36 healthy Korean subjects were enrolled in this randomized, open-label, single-dose, two-treatment, two-way crossover study. During each treatment period, subjects received the test drug (FDC tablet containing amlodipine and rosuvastatin) or reference drugs (individual tablets). Plasma samples were collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post-dose. Safety was assessed by the evaluation of adverse events (AEs), laboratory assessments, 12-lead electrocardiograms (ECGs), physical examinations, and vital sign measurements.

RESULTS

The 90% confidence intervals (CIs) of the geometric least-square mean ratios of AUClast and Cmax were 0.9796 - 1.0590 and 1.0135 - 1.0981 for amlodipine, and 0.9156 - 1.0490 and 0.8400 - 1.0306 for rosuvastatin, respectively. All AEs were of mild to moderate intensity, and no significant difference was observed in the incidence of AEs between the treatments. Moreover, the pharmacokinetic properties of the test and reference drugs were bioequivalent to each other, satisfying the regulatory criteria (0.8 - 1.25).

DISCUSSION AND CONCLUSION

Both drugs were safe and well tolerated, and the pharmacokinetic profiles were comparable between the treatments.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Equivalence Trial
Journal Article

Language

eng

PubMed ID

31549624

Citation

Park, Jeong-Soo, et al. "Pharmacokinetic and Bioequivalence Study of a Fixed-dose Combination of Amlodipine Besylate and Rosuvastatin Calcium Compared to Co-administration of Separate Tablets in Healthy Korean Subjects ." International Journal of Clinical Pharmacology and Therapeutics, vol. 57, no. 12, 2019, pp. 612-622.
Park JS, Jeon JY, Kim MG. Pharmacokinetic and bioequivalence study of a fixed-dose combination of amlodipine besylate and rosuvastatin calcium compared to co-administration of separate tablets in healthy Korean subjects . Int J Clin Pharmacol Ther. 2019;57(12):612-622.
Park, J. S., Jeon, J. Y., & Kim, M. G. (2019). Pharmacokinetic and bioequivalence study of a fixed-dose combination of amlodipine besylate and rosuvastatin calcium compared to co-administration of separate tablets in healthy Korean subjects . International Journal of Clinical Pharmacology and Therapeutics, 57(12), 612-622. https://doi.org/10.5414/CP203554
Park JS, Jeon JY, Kim MG. Pharmacokinetic and Bioequivalence Study of a Fixed-dose Combination of Amlodipine Besylate and Rosuvastatin Calcium Compared to Co-administration of Separate Tablets in Healthy Korean Subjects. Int J Clin Pharmacol Ther. 2019;57(12):612-622. PubMed PMID: 31549624.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacokinetic and bioequivalence study of a fixed-dose combination of amlodipine besylate and rosuvastatin calcium compared to co-administration of separate tablets in healthy Korean subjects . AU - Park,Jeong-Soo, AU - Jeon,Ji-Young, AU - Kim,Min-Gul, PY - 2019/11/14/accepted PY - 2019/9/25/pubmed PY - 2019/11/21/medline PY - 2019/9/25/entrez SP - 612 EP - 622 JF - International journal of clinical pharmacology and therapeutics JO - Int J Clin Pharmacol Ther VL - 57 IS - 12 N2 - CONTEXT: A fixed-dose combination (FDC) tablet of amlodipine and rosuvastatin was recently developed for the treatment of concomitant hypertension and dyslipidemia and is anticipated to improve medication compliance. OBJECTIVE: This study was performed to compare the single-dose pharmacokinetic properties and safety of DP-R212 (FDC of amlodipine and rosuvastatin) to those of each agent co-administered in healthy Korean subjects. MATERIALS AND METHODS: A total of 36 healthy Korean subjects were enrolled in this randomized, open-label, single-dose, two-treatment, two-way crossover study. During each treatment period, subjects received the test drug (FDC tablet containing amlodipine and rosuvastatin) or reference drugs (individual tablets). Plasma samples were collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post-dose. Safety was assessed by the evaluation of adverse events (AEs), laboratory assessments, 12-lead electrocardiograms (ECGs), physical examinations, and vital sign measurements. RESULTS: The 90% confidence intervals (CIs) of the geometric least-square mean ratios of AUClast and Cmax were 0.9796 - 1.0590 and 1.0135 - 1.0981 for amlodipine, and 0.9156 - 1.0490 and 0.8400 - 1.0306 for rosuvastatin, respectively. All AEs were of mild to moderate intensity, and no significant difference was observed in the incidence of AEs between the treatments. Moreover, the pharmacokinetic properties of the test and reference drugs were bioequivalent to each other, satisfying the regulatory criteria (0.8 - 1.25). DISCUSSION AND CONCLUSION: Both drugs were safe and well tolerated, and the pharmacokinetic profiles were comparable between the treatments. SN - 0946-1965 UR - https://www.unboundmedicine.com/medline/citation/31549624/Pharmacokinetic_and_bioequivalence_study_of_a_fixed_dose_combination_of_amlodipine_besylate_and_rosuvastatin_calcium_compared_to_co_administration_of_separate_tablets_in_healthy_Korean_subjects__ L2 - https://www.dustri.com/nc/journals-in-english?artId=185833 DB - PRIME DP - Unbound Medicine ER -