Pain Clinical Trial
Official title:
A Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Three Segment Cross-Over Study Investigating Oral Steady-State Pharmacokinetics And Hypoalgesic Effect Of 20 Mg Omnitram And 50 Mg Tramadol In Normal Human Subjects Made Cyp2d6 Deficient By Paroxetine
This study evaluates the analgesic effect of Omnitram and tramadol during concurrent administration of paroxetine. Paroxetine administration is expected to diminish the analgesic effect of tramadol, but not Omnitram. Each participant will receive paroxetine before and during treatment with Omnitram, tramadol, and placebo.
A randomized, double-blind, placebo-controlled study to investigating the steady-state oral
pharmacokinetics and hypoalgesic effects of overencapsulated: 20 mg Omnitram (2x10 mg
tablets), 50 mg tramadol (1x50 mg Ultram tablet), and placebo in male and female subjects
made CYP2D6 deficient by paroxetine coadministration.
Sixty participants in normal health, 18 to 50 years of age, who meet the entry criteria, will
be randomized to one of the three treatments in treatment segment 1. Each arm will ingest
three consecutive 20 mg daily doses of paroxetine. Twelve hours after the first paroxetine
dose, subjects will be randomized to one of the treatment sequences to ingest a total of 9
doses of Omnitram, tramadol, or placebo (one dose every 6 hours). Immediately before the 9th
dose a blood sample will be collected to quantify plasma Omnitram, tramadol, and paroxetine.
After the 9th study drug dose, six blood samples will be collected (1.0, 1.5, 2.0, 2.5, 4.0,
and 8.0 hours after the 9th dose is administered) to quantify the Omnitram and tramadol.
After the 9th dose, pain tolerance will be assessed with a cold pressor test (immersion of
hand in ice cold water). Participants will washout for 11-15 days after treatment 1 and
treatment 2. The study will analyze treatment side effects, the pharmacokinetics, and pain
tolerance.
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