Acute Pain Clinical Trial
Official title:
Comparative Study of the Bioavailability of Dexketoprofen Trometamol Following Single Doses of 25mg Enantyum® Oral Solution vs. Keral® Tablets in Healthy Subjects
The purpose of this study is to compare the bioavailability of 25 mg DKP.TRIS given as an Enantyum® oral solution (Test formulation) and Keral® tablet (Reference formulation). In addition, this study intends to evaluate the safety and tolerability of Test and Reference formulations.
The study was conducted in 1 site and included 26 successfully screened and randomized
healthy subjects(12 female and 14 male).
The study consisted of:
- Screening Visit (performed within 3 weeks prior to 1st PK study session), for the
evaluation of study eligibility.
- Two pharmacokinetic (PK) study sessions, separated by a minimum of a 7 day washout
period, including the administration of one out of 2 study treatments at each study
session (namely 25mg DKP.TRIS given as Enantyum® oral solution or Keral® tablet)
according to the sequence as per randomisation list, and blood sampling for PK
assessment on plasma at pre-defined time up to 24 hours post-dose.
- End of Study Visit (7-10 days after last treatment administration).
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
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