PMID- 25525378
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20141219
LR  - 20220321
IS  - 1178-7023 (Print)
IS  - 1178-7023 (Electronic)
IS  - 1178-7023 (Linking)
VI  - 7
DP  - 2014
TI  - Pharmacokinetics and safety of dexlansoprazole MR in pediatric patients with 
      symptomatic gastroesophageal reflux disease.
PG  - 461-71
LID - 10.2147/CEG.S67672 [doi]
AB  - OBJECTIVE: To evaluate the safety and pharmacokinetic profile of dexlansoprazole 
      modified-release (MR) capsules in pediatric patients with symptomatic 
      gastroesophageal reflux disease (GERD). METHODS: This Phase I, open-label study 
      enrolled male and female patients (1 to 11 years of age) with GERD. Patients 
      received dexlansoprazole MR 15 mg, 30 mg, or 60 mg (according to weight) once 
      daily for 7 days. Blood samples for the measurement of plasma dexlansoprazole 
      concentrations were collected for 24 hours after the day 7 dose. Dexlansoprazole 
      plasma concentrations and pharmacokinetic parameters were summarized by dose 
      group. Safety assessments included adverse events (AEs), clinical laboratory 
      evaluations, fasting gastrin concentrations, physical examinations, 
      electrocardiograms, and vital signs. RESULTS: Thirty-six patients received study 
      drug (12 per dose group), and 31 had evaluable pharmacokinetic data. There was a 
      significant effect of weight on dose-normalized area under the curve (AUC, 
      P=0.003) and dose-normalized maximum plasma concentration (Cmax) (P=0.013), 
      indicating that for a given dose, dexlansoprazole exposure decreases as body 
      weight increases. After adjusting for body weight, both dexlansoprazole Cmax and 
      AUC increased in an approximately dose-proportional manner with increasing 
      dexlansoprazole dose. A total of ten of 36 patients reported at least one 
      treatment-emergent AE, with most events considered mild in intensity. The most 
      common AEs were vomiting, abdominal pain, diarrhea, and nausea. CONCLUSION: In 1- 
      to 11-year-old patients with symptomatic GERD, weight-adjusted dexlansoprazole 
      AUC and Cmax increased approximately dose-proportionally. However, for a given 
      dose, dexlansoprazole exposure decreased with increasing body weight. 
      Dexlansoprazole MR was well tolerated, and the incidence of AEs did not increase 
      with increasing dose.
FAU - Kukulka, Michael
AU  - Kukulka M
AD  - Department of Clinical Pharmacology, Deerfield, IL, USA.
FAU - Nudurupati, Sai
AU  - Nudurupati S
AD  - Department of Analytical Sciences, Deerfield, IL, USA.
FAU - Perez, Maria Claudia
AU  - Perez MC
AD  - Department of Clinical Science, Takeda Development Center Americas, Inc., 
      Deerfield, IL, USA.
LA  - eng
PT  - Journal Article
DEP - 20141208
PL  - New Zealand
TA  - Clin Exp Gastroenterol
JT  - Clinical and experimental gastroenterology
JID - 101532800
PMC - PMC4266249
OTO - NOTNLM
OT  - TAK-390MR
OT  - dual delayed release
OT  - proton pump inhibitor
EDAT- 2014/12/20 06:00
MHDA- 2014/12/20 06:01
PMCR- 2014/12/08
CRDT- 2014/12/20 06:00
PHST- 2014/12/20 06:00 [entrez]
PHST- 2014/12/20 06:00 [pubmed]
PHST- 2014/12/20 06:01 [medline]
PHST- 2014/12/08 00:00 [pmc-release]
AID - ceg-7-461 [pii]
AID - 10.2147/CEG.S67672 [doi]
PST - epublish
SO  - Clin Exp Gastroenterol. 2014 Dec 8;7:461-71. doi: 10.2147/CEG.S67672. eCollection 
      2014.