Deflox Tablets Bioequivalence (BE) Trial

Study Overview
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Brief Summary
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The purpose of this study was to demonstrate the bioequivalence of Deflox® 50 milligrams (mg) tablets compared with Cataflam® DD tablets 50 mg administered as single dose in fasting conditions to healthy participants.

Official Title
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A Randomized, Open-label, Single Dose, Two-Treatment, Two Period Crossover Design (2x2), Comparative Bioequivalence Study of Deflox® Tablets 50 mg vs Cataflam DD ® Tablets 50 mg (Innovator) in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Deflox®
* Drug: Cataflam DD®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who have a body weight within 55-95 kilograms (kg) and body mass index (BMI) within the range 18.0-27.0 kilogram/meter square (kg/m2) (inclusive) Participant has given written informed consent before any study-related activities are carried out - Participants with ethnic origin: Mexicans (example: Caucasians, Indigenous peoples and Mestizos) - No smoking Participants with good physical and mental health status, determined on the basis of the medical history and a physical examination All values for biochemistry and hematology tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator Other protocol defined inclusion criteria could apply Exclusion Criteria: Participants with any surgical or medical condition, including findings in the medical history or in the pre-study assessments, or any other significant disease, that in the opinion of the investigator, constitutes a risk or a contraindication for the participation of the participant in the study or that could interfere with the study objectives, conduct or evaluation Participants with history of surgery of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility according to the Investigator's opinion Participants with allergy: ascertained or presumptive hypersensitivity to the active drug substance and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the trial A subpopulation of participants with asthma may have aspirin-sensitive asthma, which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs). Because cross-reactivity between aspirin and other NSAIDs has been report in such aspirin-sensitive patients, Cataflam is contraindicated in patients with this form of aspirin sensitivity Receipt of any prescription or non-prescription medication within 2 weeks before the first study drug administration, including multivitamins and herbal products (example: St John's Wort), including acetylsalicylic acid (ASA), and hormonal contraceptives in females Participants with renal failure or renal dysfunction (creatinine clearance < 80 milliliter per minute [mL/min]) as assessed by using the estimated measure with the Cockcroft-Gault formula Other protocol defined exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First Deflox®, Then Cataflam DD®<br>Participants received single oral dose of Deflox® 50 milligrams (mg) tablet in Treatment Period 1 followed by a single oral dose of Cataflam DD® 50 mg tablet in Treatment Period 2 under fasting condition. A wash-out period of 7 days was maintained between the Treatment Periods 1 and 2. | Drug: Deflox®<br>* Participants received a single oral dose of 50 mg Deflox® tablet in either treatment period 1 or 2 under fasting conditions.<br>* Other names: Diclofenac Potassium;Drug: Cataflam DD®<br>* Participants received a single oral dose of 50 mg Cataflam DD® tablet in either treatment period 1 or 2 under fasting conditions.<br>|
| Experimental: First Cataflam DD®, Then Deflox®<br>Participants received single oral dose of Cataflam DD® 50 mg tablet in Treatment Period 1 followed by single oral dose of Deflox® 50 mg tablet in Treatment Period 2 under fasting condition. A wash-out period of 7 days was maintained between Treatment Periods 1 and 2. | Drug: Deflox®<br>* Participants received a single oral dose of 50 mg Deflox® tablet in either treatment period 1 or 2 under fasting conditions.<br>* Other names: Diclofenac Potassium;Drug: Cataflam DD®<br>* Participants received a single oral dose of 50 mg Cataflam DD® tablet in either treatment period 1 or 2 under fasting conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Diclofenac |  | Pre-dose up to 24 hours Post-dose | 
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Diclofenac |  | Pre-dose up to 24 hours Post-dose | 
| Maximum Observed Plasma Concentration (Cmax) of Diclofenac |  | Pre-dose up to 24 hours Post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Plasma Concentration (Tmax) of Diclofenac |  | Pre-dose up to 24 hours Post-dose | 
| Terminal Elimination Half-Life (t1/2) of Diclofenac |  | Pre-dose up to 24 hours Post-dose | 
| Apparent Volume of Distribution During Terminal Phase (Vz/f) of Diclofenac |  | Pre-dose up to 24 hours Post-dose | 
| Apparent Total Body Clearance of Drug From Plasma (CL/f) of Diclofenac |  | Pre-dose up to 24 hours Post-dose | 
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs |  | Baseline up to 15 days (end of study) | 
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters |  | Baseline up to 15 days (end of study) | 
| Number of Participants With Clinically Significant Abnormalities in Vital Signs |  | Baseline up to 15 days (end of study) | 
| Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) |  | Baseline up to 15 days (end of study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deflox®, Cataflam® DD, Diclofenac potassium, Healthy