Recent Updates
Recently added Catalysts

tapentadol two 100-mg TRF

Phase 1

Healthy Volunteer | Small molecule | Other |Johnson & Johnson|Last Updated: Jan 31, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

tapentadol two 100-mg TRF · 1 trial · 1 indication

Phase 1 1
NCT01309425A Study to Compare the Dose-proportionality of Tapentadol (CG5503) in Healthy Japanese and Korean Male VolunteersHealthy Volunteer
COMPLETED52 Analytics
PHASE1COMPLETED
A Study to Compare the Dose-proportionality of Tapentadol (CG5503) in Healthy Japanese and Korean Male Volunteers
Healthy Volunteer
NCT0130942552
Unlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetic profile, as measured by Cmax, AUC, tmax, kel, t1/2
Two days

Secondary Endpoints

Number of participants with adverse events
Time of screening to end of treatment (up to 9.5 weeks)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
001EXPERIMENTALtapentadol (CG5503) ER 25-mg TRF 25mg TRF single oral dose
002EXPERIMENTALtapentadol (CG5503) ER 50-mg TRF 50mg TRF single oral dose
003EXPERIMENTALtapentadol (CG5503) ER 100-mg TRF 100mg TRF single oral dose
004EXPERIMENTALtapentadol (CG5503) ER two 100-mg TRF 200mg TRF single oral dose

Interventions

NameTypeDescription
tapentadol (CG5503) ER two 100-mg TRFDRUG200mg TRF single oral dose
tapentadol (CG5503) ER 50-mg TRFDRUG50mg TRF single oral dose
tapentadol (CG5503) ER 25-mg TRFDRUG25mg TRF single oral dose
tapentadol (CG5503) ER 100-mg TRFDRUG100mg TRF single oral dose
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy Japanese and Korean male volunteers, inclusive * Body mass index (BMI) between 18.5 and 25 kg/m², inclusive, and a body weight of not less than 50 kg * Japanese volunteers must have resided outside of Japan for no more than 5 years, and their parents and maternal and p...

Unlock Eligibility Criteria

Frequently asked questions about tapentadol two 100-mg TRF

What is tapentadol two 100-mg TRF used for?

Tapentadol two 100-mg TRF is an investigational small molecule being studied in healthy volunteers. It is a controlled, randomized Phase 1 clinical trial asset developed by Johnson & Johnson (JNJ). The drug is not approved and remains in clinical development for research purposes.

Who makes tapentadol two 100-mg TRF?

Johnson & Johnson (JNJ) is developing tapentadol two 100-mg TRF. The company conducted a Phase 1 clinical trial of this small molecule drug in healthy volunteers. The trial has been completed.

What phase is tapentadol two 100-mg TRF in?

Tapentadol two 100-mg TRF is in Phase 1 clinical development. It is an investigational drug, not FDA approved, and is being studied in healthy volunteers. One Phase 1 trial has been completed.

What clinical trials is tapentadol two 100-mg TRF in?

Tapentadol two 100-mg TRF was studied in one completed Phase 1 trial, NCT01309425, titled "A Study to Compare the Dose-proportionality of Tapentadol (CG5503) in Healthy Japanese and Korean Male Volunteers." The trial enrolled 52 male participants aged 20 years and older.

Is tapentadol two 100-mg TRF the same as CG5503?

Yes, tapentadol two 100-mg TRF is also known as CG5503. The clinical trial NCT01309425 refers to the drug as tapentadol (CG5503), confirming the alternative name.