Pharmacokinetics Clinical Trial
Official title:
Investigation of the Pharmacokinetic Characteristics of Two New CG5503 Formulations as Compared to CG5503 PR Tablets and Exploration of the Effect of Food on the Bioavailability of the Two New CG5503 Formulations Following Single Oral Administration of 116 mg CG5503 in a Single Center, Open, Randomized, 5-way-crossover, Single Dose, Phase I Study in 10 Healthy Male Subjects
This study investigated the pharmacokinetics (how a drug is taken up and excreted from the body), safety, and tolerability of 2 new tapentadol (CG5503) tablet formulations compared to a previously characterized tapentadol prolonged-release (PR) tablet formulation.
The study was performed to evaluate the pharmacokinetic characteristics (relative
bioavailability) of 2 new tapentadol (CG5503) tablet formulations (Test Product 1 and Test
Product 2) containing 116 mg tapentadol hydrochloride each, as compared to a 116-mg
tapentadol hydrochloride PR tablet (Reference Product) and to explore the effect of food on
the bioavailability of the 2 new tapentadol formulations. Participants received a single dose
of each of the test formulations under fasting or fed conditions and of the reference
formulation under fasting conditions in a randomized order. There was a wash-out period of at
least 3 days between consecutive treatments. Blood samples were taken from pre-dose up to 32
hours post-dose for pharmacokinetic analyses.
Furthermore, the study compared the safety and tolerability of the test formulations with
that of the reference. Adverse events and vital signs were documented at screening, pre-dose,
and up to 32 hours post-dose. Clinical laboratory parameters were determined and 12-lead
electrocardiograms (ECG) were recorded at screening and at discharge. A final medical
examination was performed at 2-14 days after discharge following the last treatment.
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