The purpose of this study is to compare the pharmacokinetic (PK) of single oral doses of ULTRAM Extended Release (ER) at 2 dose levels in adolescents between 12 and 17 years old, inclusive (up to 17 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.
Age range
12 Years – 17 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
The area under the curve (AUC∞) of ULTRAM ER as the primary PK parameter
Timeframe: At 1, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose