Status:
COMPLETED
Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations
Lead Sponsor:
Menarini Group
Collaborating Sponsors:
Simbec Research
Conditions:
Acute Pain
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 ...
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 pr...
Eligibility Criteria
Inclusion
- \- Healthy male and female subjects between 18 to 50 years old, with a Body Mass Index (BMI) between 18 Kg/m2 and 28 Kg/m2-
Exclusion
- History of previous allergy idiosyncrasy / sensitivity to DKP.TRIS or other NSAIDs (aspirin, ibuprofen etc).
- Any condition which might interfere with the absorption, distribution, metabolism or excretion of the drugs.
- Surgery within previous 6 months, or blood loss \> 400 mL within previous 3 months.
- Subject with positive human immunodeficiency virus (HIV), hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
- History of clinically significant alcohol, medicine or drug abuse.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02209454
Start Date
April 1 2014
End Date
June 1 2014
Last Update
July 9 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Simbec Research Limited
Merthyr Tydfil, UK, United Kingdom, CF48 4DR