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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005522-35 | EudraCT Number |
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To assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted.
This is an exploratory study to assess the influence of an opioid antagonist on the pharmacokinetics of a strong painkiller when co-administered in a fasted and fed state.
Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 32 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 hourly capsule fasted | Active Comparator | 4 mg 12 hourly capsule - strong pain killer fasted |
|
| 12 hourly capsule fed | Active Comparator | 4 mg 12 hourly capsule - strong pain killer fed |
|
| 12 hourly capsule with antagonist fasted | Experimental | 4 mg 12 hourly capsule strong painkiller with antagonist fasted |
|
| 12 hourly capsule with antagonist fed | Experimental | 4 mg 12 hourly capsule strong painkiller with antagonist fed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 mg 12 hourly capsule - strong pain killer fasted | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters AUC and Cmax | Up to 32 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | AEs will be recorded through spontaneous reporting | 7 to 10 days |
| Vital Signs | Vital signs - blood pressure, pulse rate, tympanic temperature and respiration rate |
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Healthy male or female subjects aged 18 to 55 inclusive Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical Limited | Nottingham | Nottinghamshire | NG11 6JS | United Kingdom |
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| 4 mg 12 hourly capsule - strong pain killer fed |
| Drug |
|
|
| 12 hourly capsule strong painkiller with antagonist fasted) | Drug |
|
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| 4 mg 12 hourly capsule strong painkiller with antagonist fed | Drug |
|
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| 0 to 32 hours |
| Clinical Laboratory Tests | Clinical laboratory tests - blood samples will be taken at screening and post-study medical for routine laboratory analysis (haematology, blood chemistry and urinalysis | Day 0 and Day 7-10 |
| ECG | ECGs | Screening, 1 our post-dose and Day 7-10 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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