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Pharmacokinetics of a telmisartan/rosuvastatin fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects.
Int J Clin Pharmacol Ther. 2015 Oct; 53(10):883-9.IJ

Abstract

OBJECTIVE

As hypertension and dyslipidemia are frequent comorbidities, antihypertensive drugs and lipid-lowering agents are often prescribed together for their treatment. Telmisartan and rosuvastatin are widely used together to treat hypertension and dyslipidemia. A combination formulation of these two drugs would improve patient compliance due to ease of dosing. The purpose of this study was to assess bioequivalence of single-dose administration of a newly-developed fixed-dose combination (FDC) tablet containing telmisartan/rosuvastatin 80/20 mg (test treatment) and coadministration of a telmisartan 80-mg tablet and a rosuvastatin 20-mg tablet (reference treatment) in healthy Korean male volunteers.

METHODS

This was a single-dose, randomized, open-label, 2-period crossover study enrolling healthy males aged 20 - 50 years with BMI between 18.5 and 25 kg/m2. Each subject received a single dose of the reference and test treatments with a 14-day washout period. Blood sampling was performed at prespecified intervals for up to 72 hours after dosing. Primary pharmacokinetic parameters were Cmax, AUClast, and AUC0-∞ of telmisartan, rosuvastatin, and N-desmethyl rosuvastatin. Bioequivalence was assessed by determining whether the 90% confidence intervals (CIs) of the geometric mean ratios (test treatment/reference treatment) of these parameters were within the standard range of 80% to 125%. Adverse events were monitored via regular interviews with the subjects and by physical examinations.

RESULTS

60 subjects were enrolled and 55 completed the study. The 90% CIs of the geometric mean ratios of Cmax, AUClast, and AUC00-∞ were 0.9262-1.1498, 0.9294-1.0313, and 0.9312-1.0320 for telmisartan, 0.9041-1.0428, 0.9262-1.0085, and 0.9307-1.0094 for rosuvastatin, and 0.8718-1.0022, 0.8901-0.9904, and 0.8872-0.9767 for N-desmethyl rosuvastatin, respectively. There was no statistical difference in the incidence of adverse events (AEs) (all of which were mild or moderate) between the reference and test treatments.

CONCLUSIONS

Our findings suggest that the telmisartan/rosuvastatin FDC is bioequivalent to coadministration of separate tablets, and both treatments were safe and well tolerated. Administration of this FDC tablet is expected to improve patient compliance.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26329347

Citation

Chae, Dong Woo, et al. "Pharmacokinetics of a Telmisartan/rosuvastatin Fixed-dose Combination: a Single-dose, Randomized, Open-label, 2-period Crossover Study in Healthy Korean Subjects." International Journal of Clinical Pharmacology and Therapeutics, vol. 53, no. 10, 2015, pp. 883-9.
Chae DW, Son M, Kim Y, et al. Pharmacokinetics of a telmisartan/rosuvastatin fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects. Int J Clin Pharmacol Ther. 2015;53(10):883-9.
Chae, D. W., Son, M., Kim, Y., Son, H., Jang, S. B., Seo, J. M., Nam, S. Y., & Park, K. (2015). Pharmacokinetics of a telmisartan/rosuvastatin fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects. International Journal of Clinical Pharmacology and Therapeutics, 53(10), 883-9. https://doi.org/10.5414/CP202412
Chae DW, et al. Pharmacokinetics of a Telmisartan/rosuvastatin Fixed-dose Combination: a Single-dose, Randomized, Open-label, 2-period Crossover Study in Healthy Korean Subjects. Int J Clin Pharmacol Ther. 2015;53(10):883-9. PubMed PMID: 26329347.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacokinetics of a telmisartan/rosuvastatin fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects. AU - Chae,Dong Woo, AU - Son,Mijeong, AU - Kim,Yukyung, AU - Son,Hankil, AU - Jang,Seong Bok, AU - Seo,Jeong Min, AU - Nam,Su Youn, AU - Park,Kyungsoo, PY - 2015/09/18/accepted PY - 2015/9/3/entrez PY - 2015/9/4/pubmed PY - 2015/12/15/medline SP - 883 EP - 9 JF - International journal of clinical pharmacology and therapeutics JO - Int J Clin Pharmacol Ther VL - 53 IS - 10 N2 - OBJECTIVE: As hypertension and dyslipidemia are frequent comorbidities, antihypertensive drugs and lipid-lowering agents are often prescribed together for their treatment. Telmisartan and rosuvastatin are widely used together to treat hypertension and dyslipidemia. A combination formulation of these two drugs would improve patient compliance due to ease of dosing. The purpose of this study was to assess bioequivalence of single-dose administration of a newly-developed fixed-dose combination (FDC) tablet containing telmisartan/rosuvastatin 80/20 mg (test treatment) and coadministration of a telmisartan 80-mg tablet and a rosuvastatin 20-mg tablet (reference treatment) in healthy Korean male volunteers. METHODS: This was a single-dose, randomized, open-label, 2-period crossover study enrolling healthy males aged 20 - 50 years with BMI between 18.5 and 25 kg/m2. Each subject received a single dose of the reference and test treatments with a 14-day washout period. Blood sampling was performed at prespecified intervals for up to 72 hours after dosing. Primary pharmacokinetic parameters were Cmax, AUClast, and AUC0-∞ of telmisartan, rosuvastatin, and N-desmethyl rosuvastatin. Bioequivalence was assessed by determining whether the 90% confidence intervals (CIs) of the geometric mean ratios (test treatment/reference treatment) of these parameters were within the standard range of 80% to 125%. Adverse events were monitored via regular interviews with the subjects and by physical examinations. RESULTS: 60 subjects were enrolled and 55 completed the study. The 90% CIs of the geometric mean ratios of Cmax, AUClast, and AUC00-∞ were 0.9262-1.1498, 0.9294-1.0313, and 0.9312-1.0320 for telmisartan, 0.9041-1.0428, 0.9262-1.0085, and 0.9307-1.0094 for rosuvastatin, and 0.8718-1.0022, 0.8901-0.9904, and 0.8872-0.9767 for N-desmethyl rosuvastatin, respectively. There was no statistical difference in the incidence of adverse events (AEs) (all of which were mild or moderate) between the reference and test treatments. CONCLUSIONS: Our findings suggest that the telmisartan/rosuvastatin FDC is bioequivalent to coadministration of separate tablets, and both treatments were safe and well tolerated. Administration of this FDC tablet is expected to improve patient compliance. SN - 0946-1965 UR - https://www.unboundmedicine.com/medline/citation/26329347/Pharmacokinetics_of_a_telmisartan/rosuvastatin_fixed_dose_combination:_a_single_dose_randomized_open_label_2_period_crossover_study_in_healthy_Korean_subjects_ L2 - http://www.dustri.com/nc/journals-in-english?artId=13711 DB - PRIME DP - Unbound Medicine ER -