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A Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER in Children With Pain

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · 2007
ClinicalTrials.gov · Datasets · License: Public Domain · 2007
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pain
The purpose of this study is to compare the pharmacokinetics (PK) of single oral doses of ULTRAM Extended Release (ER) at 2 dose levels in children between 7 and 11 years old, inclusive (up to 11 years 364 days) with pain due to injury or nonmalignant disease, to the PK in adults, with respect to the PK parameter AUC∞ (area under the curve) of racemic tramadol. PK explores how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time.
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