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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
BioKinetic Europe Ltd
Belfast, United Kingdom
Bioequivalence as measured by PK parameters
AUCt, AUCINF, LambdaZ, t1/2Z, Cmax and tmax
Time frame: Up to 72 hours
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.
Time frame: Up to 7-10 days after last dose
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