A single center, phase I trial to determine population pharmacokinetics of Oxycodone following an intravenous bolus

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001336

Enrollment

Registered

2015-01-06

Start date

2014-08-25

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Population pharmacokinetics of intravenous oxycodone following a single IV bolus of 0.1 mg/kg will be evaluated.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
Non-compartmental pharmacokinetics	—

Secondary

Measure	Time frame
population pharmacokinetics	—

Countries

Korea, Republic of

Contacts

Public ContactJeongsim Yang

Asan Medical Center

Outcome results