PMID- 26329347
OWN - NLM
STAT- MEDLINE
DCOM- 20151203
LR  - 20181202
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 53
IP  - 10
DP  - 2015 Oct
TI  - Pharmacokinetics of a telmisartan/rosuvastatin fixed-dose combination: a 
      single-dose, randomized, open-label, 2-period crossover study in healthy Korean 
      subjects.
PG  - 883-9
LID - 10.5414/CP202412 [doi]
AB  - 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-infinity 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-infinity 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.
FAU - Chae, Dong Woo
AU  - Chae DW
FAU - Son, Mijeong
AU  - Son M
FAU - Kim, Yukyung
AU  - Kim Y
FAU - Son, Hankil
AU  - Son H
FAU - Jang, Seong Bok
AU  - Jang SB
FAU - Seo, Jeong Min
AU  - Seo JM
FAU - Nam, Su Youn
AU  - Nam SY
FAU - Park, Kyungsoo
AU  - Park K
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 0 (Benzimidazoles)
RN  - 0 (Benzoates)
RN  - 0 (Drug Combinations)
RN  - 83MVU38M7Q (Rosuvastatin Calcium)
RN  - U5SYW473RQ (Telmisartan)
SB  - IM
MH  - Adult
MH  - Benzimidazoles/administration & dosage/adverse effects/*pharmacokinetics
MH  - Benzoates/administration & dosage/adverse effects/*pharmacokinetics
MH  - Cross-Over Studies
MH  - Drug Combinations
MH  - Humans
MH  - Male
MH  - Rosuvastatin Calcium/administration & dosage/adverse effects/*pharmacokinetics
MH  - Telmisartan
EDAT- 2015/09/04 06:00
MHDA- 2015/12/15 06:00
CRDT- 2015/09/03 06:00
PHST- 2015/09/18 00:00 [accepted]
PHST- 2015/09/03 06:00 [entrez]
PHST- 2015/09/04 06:00 [pubmed]
PHST- 2015/12/15 06:00 [medline]
AID - 13711 [pii]
AID - 10.5414/CP202412 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2015 Oct;53(10):883-9. doi: 10.5414/CP202412.