PMID- 28079517
OWN - NLM
STAT- MEDLINE
DCOM- 20171103
LR  - 20221222
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 55
IP  - 3
DP  - 2017 Mar
TI  - 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
.
PG  - 286-294
LID - 10.5414/CP202740 [doi]
AB  - 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 C(max), AUC(last), and AUC(inf) 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.
.
FAU - Park, Dan-Bee
AU  - Park DB
FAU - Jang, Kyungho
AU  - Jang K
FAU - Lee, Jae-Won
AU  - Lee JW
FAU - Park, Cheol-Won
AU  - Park CW
FAU - Lee, Back-Hwan
AU  - Lee BH
FAU - Kim, Min-Gul
AU  - Kim MG
FAU - Jeon, Ji-Young
AU  - Jeon JY
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 0 (Angiotensin II Type 1 Receptor Blockers)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Benzimidazoles)
RN  - 0 (Biphenyl Compounds)
RN  - 0 (Drug Combinations)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Tablets)
RN  - 0 (Tetrazoles)
RN  - 83MVU38M7Q (Rosuvastatin Calcium)
RN  - R85M2X0D68 (candesartan cilexetil)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Angiotensin II Type 1 Receptor Blockers/administration & dosage/adverse 
      effects/blood/*pharmacokinetics
MH  - Antihypertensive Agents/administration & dosage/adverse 
      effects/blood/*pharmacokinetics
MH  - Area Under Curve
MH  - Asian People
MH  - Benzimidazoles/administration & dosage/adverse effects/blood/*pharmacokinetics
MH  - Biphenyl Compounds/administration & dosage/adverse 
      effects/blood/*pharmacokinetics
MH  - Cross-Over Studies
MH  - Drug Combinations
MH  - Half-Life
MH  - Healthy Volunteers
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage/adverse 
      effects/blood/*pharmacokinetics
MH  - Male
MH  - Metabolic Clearance Rate
MH  - Middle Aged
MH  - Republic of Korea
MH  - Rosuvastatin Calcium/administration & dosage/adverse 
      effects/blood/*pharmacokinetics
MH  - Tablets
MH  - Tetrazoles/administration & dosage/adverse effects/blood/*pharmacokinetics
MH  - Therapeutic Equivalency
MH  - Young Adult
EDAT- 2017/01/13 06:00
MHDA- 2017/11/04 06:00
CRDT- 2017/01/13 06:00
PHST- 2017/02/14 00:00 [accepted]
PHST- 2017/01/13 06:00 [pubmed]
PHST- 2017/11/04 06:00 [medline]
PHST- 2017/01/13 06:00 [entrez]
AID - 15094 [pii]
AID - 10.5414/CP202740 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2017 Mar;55(3):286-294. doi: 10.5414/CP202740.