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HealthyPhase 1NCT04132583

Deflox Tablets Bioequivalence (BE) Trial

A Phase 1 study testing Deflox® and Cataflam DD® in people with Healthy, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Deflox® and Cataflam DD®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteMexico
Study dates
21 Sep 2019to 27 Oct 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Mexico1 site

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

    Morelia

Other trials in Mexico

About this study

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

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.

Conditions
Healthy
Being tested
Deflox®, Cataflam DD®
Keywords
Deflox®, Cataflam® DD, Diclofenac potassium, Healthy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deflox®Drug

    Also called Diclofenac Potassium

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

  • 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.

Study groups in NCT04132583
Study groupRoleWhat they receive
First Deflox®, Then Cataflam DD®ExperimentalParticipants 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.
Receives: Drug: Deflox®; Drug: Cataflam DD®
First Cataflam DD®, Then Deflox®ExperimentalParticipants 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.
Receives: Drug: Deflox®; Drug: Cataflam DD®

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    Measured: Pre-dose up to 24 hours Post-dose

  3. Maximum Observed Plasma Concentration (Cmax) of Diclofenac

    Measured: Pre-dose up to 24 hours Post-dose

Secondary outcomes (8)

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

    Measured: Pre-dose up to 24 hours Post-dose

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

    Measured: Pre-dose up to 24 hours Post-dose

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

    Measured: Pre-dose up to 24 hours Post-dose

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

    Measured: Pre-dose up to 24 hours Post-dose

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

    Measured: Baseline up to 15 days (end of study)

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

    Measured: Baseline up to 15 days (end of study)

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

    Measured: Baseline up to 15 days (end of study)

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

    Measured: Baseline up to 15 days (end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start21 Sep 2019
  3. Primary completion27 Oct 2019
  4. Study completion27 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04132583
Sponsor's protocol ID
MS200505_0003
Status last verified
Feb 2021
First submitted
17 Oct 2019
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Deflox® and Cataflam DD® in people with Healthy, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04132583.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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Deflox Tablets Bioequivalence (BE) Trial (NCT04132583) | AzTrials