Phase 1
Completed N=26
Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations
Source: ClinicalTrials.gov NCT02209454 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: Cmax — 3290.70; 2785.90 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax |
3290.70; 2785.90 | — |
| PRIMARY AUC(0-t) |
3362.20; 3372.00 | — |
| SECONDARY AUC(0-∞) |
3473.00; 3485.60 | — |
| SECONDARY Tmax |
0.25; 0.50 | — |
| SECONDARY t1/2 |
1.34; 1.30 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02209454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.