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Deflox

Phase 4

Undisclosed | Small molecule | Other |Merck KGaA|Trials Updated: Feb 24, 2021

Deflox development status

Highest phase Phase 4 run by Novartis Pharmaceuticals (NCT01019980)
Phase scored for MKGAFPhase 1
Registered trials 4 across 2 sponsors since Nov 2009

Deflox target and mechanism

ModalitySmall molecule

Also known as Diclofenac Potassium

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Deflox clinical trials

Deflox · 1 trial · 1 indication

Phase 1 1
NCT04132583Deflox Tablets Bioequivalence (BE) TrialHealthy
COMPLETED16 Analytics
PHASE1COMPLETED
Deflox Tablets Bioequivalence (BE) Trial
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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.
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.

Interventions

NameTypeDescription
Deflox®DRUGParticipants received a single oral dose of 50 mg Deflox® tablet in either treatment period 1 or 2 under fasting conditions.
Cataflam DD®DRUGParticipants received a single oral dose of 50 mg Cataflam DD® tablet in either treatment period 1 or 2 under fasting conditions.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 wi...

Countries:Mexico
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Frequently asked questions about Deflox

What is Deflox?

Deflox is an investigational small molecule developed by Merck KGaA. It has been studied in a Phase 1 bioequivalence trial in healthy adult volunteers. The specific therapeutic indication for Deflox has not been publicly disclosed.

Who makes Deflox?

Deflox is developed by Merck KGaA, which trades under the ticker MKGAF. The company sponsored the clinical trial evaluating Deflox tablets.

What phase is Deflox in?

Deflox is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational agent and has not been approved by the FDA.

What clinical trials has Deflox been studied in?

Deflox has been evaluated in one completed Phase 1 trial, NCT04132583, titled the Deflox Tablets Bioequivalence (BE) Trial. The trial enrolled 16 healthy adult volunteers in Mexico and used a randomized, controlled design.

Is Deflox the same as Deflox®?

Yes, Deflox and Deflox® refer to the same investigational small molecule developed by Merck KGaA. The registered trademark symbol is simply a stylized version of the same drug name used in official documentation.