A Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER in Children With Pain
Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.