At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
Enantyum® oral solution +1 moredrug
Likely dose
Enantyum® oral solution 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparative Study of the Bioavailability of Dexketoprofen Trometamol Following Single Doses of 25mg Enantyum® Oral Solution vs. Keral® Tablets in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Enantyum® oral solution and Keral® tablet for Acute Pain. Completed, enrolled 26 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesUnited Kingdom
CollaboratorsSimbec Research
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
Primary CompletionMay 2014
Study CompletionJun 2014
First PostedAug 2014
TodayJul 2026
First PostedAug 6, 2014
Enrollment StartApr 1, 2014
Primary CompletionMay 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.9 years ago
Interventions
Enantyum® oral solutiondrug
One dose of 25 mg DKP oral solution
Keral® tabletdrug
One dose of 25 mg DKP tablet