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To determine whether three new oral formulations of a strong pain killer release the drug into the body in a similar pattern as the already marketed reference capsule formulation with or without food
Comparisons will be made between three new oral formulations and an existing marketed reference capsule formulation to determine whether the release rates of the products are similar or equivalent in a fed or fasted state. Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 72 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 |
|---|---|---|---|
| MRXXX | Active Comparator | Active comparator |
|
| MR1XXX | Experimental | MR1XXX |
|
| MR2XXX | Experimental | MR2XXX |
|
| MR3XXX | Experimental | MR3XXX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRXXX | Drug |
| ||
| MR1XXX |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence as measured by PK parameters | AUCt, AUCINF, LambdaZ, t1/2Z, Cmax and tmax | Up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as measured by adverse events, vital signs, clinical lab results and ECGs. | Collection of adverse events, vital signs, clinical lab results and ECGs. | Up to 7-10 days after last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioKinetic Europe Ltd | Belfast | United Kingdom |
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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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| MR2XXX | Drug |
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| MR3XXX | Drug |
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