PMID- 31549624
OWN - NLM
STAT- MEDLINE
DCOM- 20191120
LR  - 20200108
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 57
IP  - 12
DP  - 2019 Dec
TI  - 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
.
PG  - 612-622
LID - 10.5414/CP203554 [doi]
AB  - 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 AUC(last) and C(max) 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.
FAU - Park, Jeong-Soo
AU  - Park JS
FAU - Jeon, Ji-Young
AU  - Jeon JY
FAU - Kim, Min-Gul
AU  - Kim MG
LA  - eng
PT  - Equivalence Trial
PT  - Journal Article
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 0 (Drug Combinations)
RN  - 0 (Tablets)
RN  - 1J444QC288 (Amlodipine)
RN  - 83MVU38M7Q (Rosuvastatin Calcium)
SB  - IM
MH  - Administration, Oral
MH  - Amlodipine/*administration & dosage/pharmacokinetics
MH  - Area Under Curve
MH  - Cross-Over Studies
MH  - Drug Combinations
MH  - Drug Therapy, Combination
MH  - Healthy Volunteers
MH  - Humans
MH  - Republic of Korea
MH  - Rosuvastatin Calcium/*administration & dosage/pharmacokinetics
MH  - Tablets
MH  - Therapeutic Equivalency
EDAT- 2019/09/25 06:00
MHDA- 2019/11/21 06:00
CRDT- 2019/09/25 06:00
PHST- 2019/11/14 00:00 [accepted]
PHST- 2019/09/25 06:00 [pubmed]
PHST- 2019/11/21 06:00 [medline]
PHST- 2019/09/25 06:00 [entrez]
AID - 185833 [pii]
AID - 10.5414/CP203554 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2019 Dec;57(12):612-622. doi: 10.5414/CP203554.