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Deflox

Phase 1

Healthy | Small molecule | Other |Merck KGaA|Last Updated: Feb 24, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

Deflox is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development. The only completed trial evaluated Deflox tablets for bioequivalence in healthy participants. Deflox is not approved and remains in clinical development.

Who makes Deflox?

Deflox is being developed by Merck KGaA, a company traded under the ticker MKGAF. The developer is responsible for the ongoing clinical development of this investigational small molecule.

What phase is Deflox in?

Deflox is in Phase 1 clinical development. The single trial listed for Deflox is a Phase 1 study that has been completed. Deflox is an investigational drug and has not been approved.

What clinical trials is Deflox in?

Deflox has one clinical trial, NCT04132583, titled "Deflox Tablets Bioequivalence (BE) Trial." This Phase 1 study enrolled 16 healthy volunteers in Mexico and has been completed. The trial was randomized and controlled.

Is Deflox FDA approved?

Deflox is not FDA approved. It is an investigational small molecule currently in Phase 1 clinical development. The available data shows one completed Phase 1 trial, but no approval status has been established.