Deflox Tablets Bioequivalence (BE) Trial

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Deflox®; Drug: Cataflam DD®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04132583

MS200505_0003

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

First Deflox®, Then Cataflam DD®

Experimental group

Description:

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.

Treatment:

Drug: Deflox®

Drug: Cataflam DD®

First Cataflam DD®, Then Deflox®

Experimental group

Description:

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.

Treatment:

Drug: Deflox®

Drug: Cataflam DD®