Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations

Acute Pain Clinical Trial

Official title:

Comparative Study of the Bioavailability of Dexketoprofen Trometamol Following Single Doses of 25mg Enantyum® Oral Solution vs. Keral® Tablets in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209454
• Other study ID #: RD 303/25652(DKP-BE-SOL)
• Secondary ID: 2014-000371-10
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2014
• Last updated: June 16, 2015
• Start date: April 2014
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: Menarini Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Enantyum® oral solution
One dose of 25 mg DKP oral solution
• Keral® tablet
One dose of 25 mg DKP tablet

Locations

Country	Name	City	State
United Kingdom	Simbec Research Limited	Merthyr Tydfil	UK

Sponsors (2)

Lead Sponsor	Collaborator
Menarini Group	Simbec Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 133.00% for Cmax.	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).	No
Primary	AUC(0-t)	The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 125.00% for AUC(0-t).	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).	No
Secondary	AUC(0-8)	AUC(0-8) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.	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).	No
Secondary	Tmax	AUC(0-8) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax).	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).	No
Secondary	t1/2	AUC(0-8) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.	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).	No