Study C03-043
A Phase I, Single- and Repeated- Dose, Randomized, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics Pharmacodynamics and Safety of Lansoprazole in Infants with Clinically-Evident Gastroesophageal Reflux Disease.
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To view this study on clinicaltrials.gov: http://www.clinicaltrials.gov/ct/show/NCT00220818
For FDA Safety Alerts and Recalls refer to the following link: www.fda.gov/MEDWATCH/safety.htm
Springer M, Atkinson S, North J, Raanan M.
Safety and pharmacodynamics of lansoprazole in patients with gastroesophageal reflux disease aged <1 year.
Pediatr Drugs. 2008 Apr;10(4):255-263.
PubMed Number:18590344
Zhang W, Kukulka M, Witt G, Sutkowski-Markmann D, North J, Atkinson S.
Age-dependent pharmacokinetics of lansoprazole in neonates and infants.
Pediatr Drugs. 2008 Apr;10(4):265-274.
PubMed Number:18590345
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