Clinical trial NCT02209454: Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations
Official title: Comparative Study of the Bioavailability of Dexketoprofen Trometamol Following Single Doses of 25mg Enantyum® Oral Solution vs. Keral® Tablets in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Pain
Keywords: Dexketoprofen
Bioavailability
Comparative
Pharmacokinetic
Lead sponsor: Menarini Group
Sponsor class: INDUSTRY
Collaborators: name: Simbec Research
First posted: 2014-08-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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 intends to evaluate the safety and tolerability of Test and Reference formulations.

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 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).

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.

Primary outcomes:
measure: Cmax
timeFrame: Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).
measure: AUC(0-t)
timeFrame: Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).
Secondary outcomes:
measure: AUC(0-∞)
timeFrame: Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).
measure: Tmax
timeFrame: Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).
measure: t1/2
timeFrame: Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec Research Limited
state: UK
Study officials:
affiliation: Simbec Research
name: Girish Sharma, MBBS
role: PRINCIPAL_INVESTIGATOR
References: