Pharmacokinetics And Relative Bioavailability Study Of Oxycodone

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552850
• Other study ID #: B4501010
• Status: Completed
• Phase: Phase 1
• First received: March 9, 2012
• Last updated: August 28, 2015
• Start date: April 2012
• Est. completion date: June 2012

Study information

• Verified date: August 2015
• Source: Pain Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

This study will estimate the PK and relative bioavailability of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations B, C, and D compared with the reference Formulation A under fed conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Oxycodone
1X40 mg PF-00345439 formulation A capsule with water and under fed condition
• Oxycodone
1X40 mg PF-00345439 formulation B capsule with water and under fed condition
• Oxycodone
1X40 mg PF-00345439 formulation C capsule with water and under fed condition
• Oxycodone
1X40 mg PF-00345439 formulation D capsule with water and under fed condition
• Oxycodone
40 mg oxycodone oral solution (5 mg/5 ml) with water and under fed condition

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pain Therapeutics

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose	No
Primary	Maximum Observed Plasma Concentration (Cmax)		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit.		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit.		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose	No
Secondary	Plasma Decay Half-Life of oxycodone, as data permit.		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose	No
Secondary	Concentration at time 24 hours (C24) of oxycodone, as data permit.		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose	No
Secondary	Adverse events, vital signs and laboratory parameters.		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose	Yes

External Links

•   To obtain contact information for a study center near you, click here.