Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Menarini Group
• Collaborator: Simbec Research
• Treatments: Dexketoprofen trometamol; Ketoprofen; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.