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Completed

NCT Number: NCT04132583

Deflox Tablets Bioequivalence (BE) Trial

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinica de Enfermedades Crónicas y de Procedimientos Especiales S.C.

Morelia, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deflox®

Drug

Participants received a single oral dose of 50 mg Deflox® tablet in either treatment period 1 or 2 under fasting conditions.

Other names: Diclofenac Potassium

Cataflam DD®

Drug

Participants received a single oral dose of 50 mg Cataflam DD® tablet in either treatment period 1 or 2 under fasting conditions.

Primary outcomes

  1. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Diclofenac

    Time frame: Pre-dose up to 24 hours Post-dose

  2. Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Diclofenac

    Time frame: Pre-dose up to 24 hours Post-dose

  3. Maximum Observed Plasma Concentration (Cmax) of Diclofenac

    Time frame: Pre-dose up to 24 hours Post-dose

Secondary outcomes

  1. Time to Reach Maximum Plasma Concentration (Tmax) of Diclofenac

    Time frame: Pre-dose up to 24 hours Post-dose

  2. Terminal Elimination Half-Life (t1/2) of Diclofenac

    Time frame: Pre-dose up to 24 hours Post-dose

  3. Apparent Volume of Distribution During Terminal Phase (Vz/f) of Diclofenac

    Time frame: Pre-dose up to 24 hours Post-dose

  4. Apparent Total Body Clearance of Drug From Plasma (CL/f) of Diclofenac

    Time frame: Pre-dose up to 24 hours Post-dose

  5. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

    Time frame: Baseline up to 15 days (end of study)

  6. Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

    Time frame: Baseline up to 15 days (end of study)

  7. Number of Participants With Clinically Significant Abnormalities in Vital Signs

    Time frame: Baseline up to 15 days (end of study)

  8. Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG)

    Time frame: Baseline up to 15 days (end of study)

Sponsors and collaborators

Lead sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 21, 2019
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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