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To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone Formulation A Capsule | Experimental | single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block |
|
| Oxycodone Formulation B Capsule | Experimental | single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block |
|
| Oxycodone Formulation C Capsule | Experimental | single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block |
|
| Oxycodone Formulation D Capsule | Experimental | single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block |
|
| Oxycodone Oral Solution | Experimental | 40 mg oxycodone oral solution (5 mg/5 ml) under 50 mg naltrexone block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | 1X40 mg PF-00345439 formulation A capsule with water and under fed condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Maximum Observed Plasma Concentration (Cmax) | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Singapore | Singapore | 188770 | Singapore |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Oxycodone | Drug | 1X40 mg PF-00345439 formulation B capsule with water and under fed condition |
|
| Oxycodone | Drug | 1X40 mg PF-00345439 formulation C capsule with water and under fed condition |
|
| Oxycodone | Drug | 1X40 mg PF-00345439 formulation D capsule with water and under fed condition |
|
| Oxycodone | Drug | 40 mg oxycodone oral solution (5 mg/5 ml) with water and under fed condition |
|
| 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose |
| 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 |
| 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 |
| Adverse events, vital signs and laboratory parameters. | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |