Pharmacokinetics And Relative Bioavailability Study Of Oxycodone
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Management of Moderate to Severe Pain
Intervention: Oxycodone (Drug); Oxycodone (Drug); Oxycodone (Drug); Oxycodone (Drug); Oxycodone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To estimate the pharmacokinetics and relative bioavailability of oxycodone after
administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution
Clinical Details
Official title: An Open-Label, Single-Dose, Randomized, Crossover Pharmacokinetics And Relative Bioavailability Study Of Three Modified 40 Mg Oxycodone Formulations Compared With 40 Mg Pf-00345439 Capsule Formulation In Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone.Maximum Observed Plasma Concentration (Cmax)
Secondary outcome: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit.Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit. Plasma Decay Half-Life of oxycodone, as data permit. Concentration at time 24 hours (C24) of oxycodone, as data permit. Adverse events, vital signs and laboratory parameters.
Eligibility
Minimum age: 21 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive
Exclusion Criteria:
- Evidence or history of clinically significant diseases
Locations and Contacts
Pfizer Investigational Site, Singapore 188770, Singapore
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 2012
Last updated: June 26, 2012
|
