Healthy
Conditions
Keywords
Deflox®, Cataflam® DD, Diclofenac potassium, Healthy
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.
Interventions
DRUGDeflox®
Participants received a single oral dose of 50 mg Deflox® tablet in either treatment period 1 or 2 under fasting conditions.
DRUGCataflam DD®
Participants received a single oral dose of 50 mg Cataflam DD® tablet in either treatment period 1 or 2 under fasting conditions.
Sponsors
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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) |
| Time to Reach Maximum Plasma Concentration (Tmax) of Diclofenac | Pre-dose up to 24 hours Post-dose |
| 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) |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Baseline up to 15 days (end of study) |
| 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 |
Countries
Mexico
Outcome results
None listed