A single center, phase I trial to determine population pharmacokinetics of Oxycodone following an intravenous bolus
- Conditions
- Not Applicable
- Registration Number
- KCT0001336
- Lead Sponsor
- Mundipharma Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
20 years old or above male or female Korean patients
-American Society of Anesthesiologist Physical Status 1 or 2
-Patients undergoing stomach, colorectal, or hepatobiliary surgeries
-Patients who signed a written informed consent form
-Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
-Patients with known hypersensitivity to intervention treatments (oxycodone) or to any of the excipients
-Patients with severely impaired respiratory function or respiratory depression status
-Patients concurrently receiving MAOIs or who have received MAOIs within the previous two weeks
-Patients with convulsive disorders, head injury, shock, a reduced level of consciousness of uncertain origin, intracranial lesions or increased intracranial pressure, or in patients with severe hepatic impairment
-Patients with biliary tract disorders
-Patients who are concurrently taking other CNS (central nervous system) depressants that may cause respiratory depression, hypotension, profound sedation or potentially result in coma.
-Any situation where oxycodone is contraindicated as detailed in the investigator’s brochure or prescribing information
-Clinically significant impairment of cardiovascular, respiratory and renal function
-Patients who are considered by the investigator to be unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method on-compartmental pharmacokinetics
- Secondary Outcome Measures
Name Time Method population pharmacokinetics