NCT02209454

Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations

Comparative Study of the Bioavailability of Dexketoprofen Trometamol Following Single Doses of 25mg Enantyum® Oral Solution vs. Keral® Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Menarini Group · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Enantyum® oral solution	One dose of 25 mg DKP oral solution
DRUG	Keral® tablet	One dose of 25 mg DKP tablet

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2014-08-06
• Last updated: 2015-07-09
• Results posted: 2015-07-09

Locations

1 site across 1 country: United Kingdom