Conditions: Acute Pain
Keywords: Dexketoprofen Bioavailability Comparative Pharmacokinetic
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 26
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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).

Arms:
arm 1: 25mg DKP.TRIS oral solution arm 2: 25mg DKP.TRIS tablet

Interventions: intervention 1: Enantyum® oral solution intervention 2: Keral® tablet
Intervention descriptions: intervention 1: One dose of 25 mg DKP oral solution intervention 2: One dose of 25 mg DKP tablet

Protocol document: