Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations

• ClinicalTrials.gov Identifier: NCT02209454
• Recruitment Status: Completed
• First Posted: August 6, 2014
• Results First Posted: July 9, 2015
• Last Update Posted: July 9, 2015
• Sponsor: Menarini Group
• Collaborator: Simbec Research
• Information provided by (Responsible Party): Menarini Group

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Pain	Drug: Enantyum® oral solution; Drug: Keral® tablet	Phase 1

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• 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 Start Date: April 2014
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm	Intervention/treatment
Enantyum® oral solution; 25mg DKP.TRIS oral solution	Drug: Enantyum® oral solution; One dose of 25 mg DKP oral solution
Keral® tablet; 25mg DKP.TRIS tablet	Drug: Keral® tablet; One dose of 25 mg DKP tablet

Outcome Measures

Primary Outcome Measures :

1. Cmax [ Time Frame: 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). ]
   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.
2. AUC(0-t) [ Time Frame: 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). ]
   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).

Secondary Outcome Measures :

1. AUC(0-∞) [ Time Frame: 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). ]
   AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.
2. Tmax [ Time Frame: 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). ]
   AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax).
3. t1/2 [ Time Frame: 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). ]
   AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United Kingdom

Simbec Research Limited

Merthyr Tydfil, UK, United Kingdom, CF48 4DR

Sponsors and Collaborators

Menarini Group

Simbec Research

Investigators

• Principal Investigator: Girish Sharma, MBBS; Simbec Research

More Information

• Responsible Party: Menarini Group
• ClinicalTrials.gov Identifier: NCT02209454
• Other Study ID Numbers: RD 303/25652(DKP-BE-SOL); 2014-000371-10 ( EudraCT Number )
• First Posted: August 6, 2014
• Results First Posted: July 9, 2015
• Last Update Posted: July 9, 2015
• Last Verified: May 2015

Keywords provided by Menarini Group:

Dexketoprofen; Bioavailability; Comparative; Pharmacokinetic

Additional relevant MeSH terms:

Acute Pain; Pain; Neurologic Manifestations; Dexketoprofen trometamol; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents