Deflox Tablets Bioequivalence (BE) Trial
- Registration Number
- NCT04132583
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description First Deflox®, Then Cataflam DD® Deflox® 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. First Deflox®, Then Cataflam DD® Cataflam DD® 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. First Cataflam DD®, Then Deflox® Deflox® 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. First Cataflam DD®, Then Deflox® Cataflam DD® 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.
- Primary Outcome Measures
Name Time Method 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 Maximum Observed Plasma Concentration (Cmax) 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
- Secondary Outcome Measures
Name Time Method 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 12-lead Electrocardiogram (ECG) 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)
Trial Locations
- Locations (1)
Clinica de Enfermedades Crónicas y de Procedimientos Especiales S.C.
🇲🇽Morelia, Mexico