Clinical trial NCT04132583: Deflox Tablets Bioequivalence (BE) Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Deflox®
Cataflam® DD
Diclofenac potassium
Healthy
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2019-10-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Diclofenac
timeFrame: Pre-dose up to 24 hours Post-dose
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Diclofenac
timeFrame: Pre-dose up to 24 hours Post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of Diclofenac
timeFrame: Pre-dose up to 24 hours Post-dose
Secondary outcomes:
measure: Time to Reach Maximum Plasma Concentration (Tmax) of Diclofenac
timeFrame: Pre-dose up to 24 hours Post-dose
measure: Terminal Elimination Half-Life (t1/2) of Diclofenac
timeFrame: Pre-dose up to 24 hours Post-dose
measure: Apparent Volume of Distribution During Terminal Phase (Vz/f) of Diclofenac
timeFrame: Pre-dose up to 24 hours Post-dose
measure: Apparent Total Body Clearance of Drug From Plasma (CL/f) of Diclofenac
timeFrame: Pre-dose up to 24 hours Post-dose
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: Baseline up to 15 days (end of study)
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
timeFrame: Baseline up to 15 days (end of study)
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: Baseline up to 15 days (end of study)
measure: Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG)
timeFrame: Baseline up to 15 days (end of study)
Other outcomes:
Locations:
city: Morelia
country: Mexico
facility: Clinica de Enfermedades Crónicas y de Procedimientos Especiales S.C.
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: