Deflox Tablets Bioequivalence (BE) Trial

Healthy Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04132583
• Other study ID #: MS200505_0003
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2019
• Est. completion date: October 27, 2019

Study information

• Verified date: February 2021
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 27, 2019
• Est. primary completion date: October 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Mexico	Clinica de Enfermedades Crónicas y de Procedimientos Especiales S.C.	Morelia

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Diclofenac		Pre-dose up to 24 hours Post-dose
Primary	Maximum Observed Plasma Concentration (Cmax) of Diclofenac		Pre-dose up to 24 hours Post-dose
Secondary	Time to Reach Maximum Plasma Concentration (Tmax) of Diclofenac		Pre-dose up to 24 hours Post-dose
Secondary	Terminal Elimination Half-Life (t1/2) of Diclofenac		Pre-dose up to 24 hours Post-dose
Secondary	Apparent Volume of Distribution During Terminal Phase (Vz/f) of Diclofenac		Pre-dose up to 24 hours Post-dose
Secondary	Apparent Total Body Clearance of Drug From Plasma (CL/f) of Diclofenac		Pre-dose up to 24 hours Post-dose
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs		Baseline up to 15 days (end of study)
Secondary	Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters		Baseline up to 15 days (end of study)
Secondary	Number of Participants With Clinically Significant Abnormalities in Vital Signs		Baseline up to 15 days (end of study)
Secondary	Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG)		Baseline up to 15 days (end of study)

External Links

•   Trial Awareness and Transparency website