Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations

Menarini

Status and phase

Completed

Phase 1

Conditions

Acute Pain

Treatments

Drug: Enantyum® oral solution

Drug: Keral® tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT02209454

2014-000371-10 (EudraCT Number)

RD 303/25652(DKP-BE-SOL)

Details and patient eligibility

About

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.

Full 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).

Enrollment

26 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.