A Study to Evaluate the Drug-Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen
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|ClinicalTrials.gov Identifier: NCT02848729|
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Information provided by (Responsible Party):
This study is to test the hypothesis that an opioid used to treat postsurgical pain, IV morphine, will impact the absorption of coadministered oral acetaminophen and result in altered pharmacokinetics in healthy subjects.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Acetaminophen (APAP) tablets Drug: IV acetaminophen (APAP) Drug: IV morphine||Phase 4|
Acetaminophen can significantly reduce the use of opioid analgesics when both are used concomitantly for treating moderate to severe pain. The use of IV acetaminophen used concomitantly with opioids has increased in practice for postsurgical pain relief over orally administered acetaminophen because it provides an immediate peak plasma concentration and is believed to provide a faster analgesic effect. Opioids used to treat pain inhibit gastrointestinal motility, including delaying gastric emptying. In patients receiving opioids the absorption of orally administered acetaminophen may be delayed and could result in gastric accumulation of acetaminophen thereby markedly changing the pharmacokinetic profile. The opioid-induced inhibition of gastrointestinal motility would not be expected to affect IV acetaminophen pharmacokinetics. Thus coadministered IV acetaminophen with opioid would yield better outcome in efficacy and reduced risk of side effects comparing with coadministration of oral acetaminophen and opioids.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, 2-Way, Parallel, Single-Blind Pharmacokinetic Study to Evaluate the Interaction Between Intravenous Morphine and Orally or Intravenously Administered Acetaminophen in Healthy Subjects|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||May 2016|
Experimental: Oral acetaminophen
Four doses of 1,000 mg oral APAP (2 tablets, 500 mg/tablet), Q6h, Dose 2 and 3 are co-administered with IV morphine
Drug: Acetaminophen (APAP) tablets
Drug: IV morphine
Experimental: IV acetaminophen
Four doses of IV APAP (1000 mg/100 mL), Q6h, Dose 2 and 3 are co-administered with IV morphine
Drug: IV acetaminophen (APAP)
Drug: IV morphine
Primary Outcome Measures :
- Area Under the plasma concentration-time curve (AUC) of oral acetaminophen [ Time Frame: Hour -6 to 0, Hour 0 to 6, Hour 12 to 18 ]To evaluate the effect of co-administered morphine on acetaminophen's pharmacokinetics before, during, and after co-administration.
- Maximum observed plasma concentration (Cmax) of oral acetaminophen [ Time Frame: Hour -6 to 0, Hour 0 to 6, Hour 12 to 18 ]To evaluate the effect of co-administered morphine on acetaminophen's pharmacokinetics before, during, and after co-administration.
- Time to achieve the maximum observed plasma concentration (Tmax) of oral acetaminophen [ Time Frame: Hour -6 to 0, Hour 0 to 6, Hour 12 to 18 ]To evaluate the effect of co-administered morphine on acetaminophen's pharmacokinetics before, during, and after co-administration.
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