Deflox Tablets Bioequivalence (BE) Trial

NCT04132583 | Completed Phase 1

• 1 other identifier: MS200505_0003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Deflox®; Cataflam® DD; Diclofenac potassium; Healthy

Outcome Measures

Primary Outcomes (3)

• 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

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

  Pre-dose up to 24 hours Post-dose

• Maximum Observed Plasma Concentration (Cmax) of Diclofenac

  Pre-dose up to 24 hours Post-dose

Secondary Outcomes (8)

• Time to Reach Maximum Plasma Concentration (Tmax) of Diclofenac

  Pre-dose up to 24 hours Post-dose

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

  Pre-dose up to 24 hours Post-dose

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

  Pre-dose up to 24 hours Post-dose

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

  Pre-dose up to 24 hours Post-dose

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

  Baseline up to 15 days (end of study)

Study Arms (2)

First Deflox®, Then Cataflam DD®

EXPERIMENTAL

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.

Drug: Deflox®; Drug: Cataflam DD®

First Cataflam DD®, Then Deflox®

EXPERIMENTAL

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.

Drug: Deflox®; Drug: Cataflam DD®

Interventions

Deflox® DRUG

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

Also known as: Diclofenac Potassium

First Cataflam DD®, Then Deflox®; First Deflox®, Then Cataflam DD®

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.

First Cataflam DD®, Then Deflox®; First Deflox®, Then Cataflam DD®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

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

Morelia, Mexico

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Interventions

Terazosin; Diclofenac

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Medical Responsible

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: September 21, 2019
• Primary Completion: October 27, 2019
• Study Completion: October 27, 2019
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)