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tapentadol 25-mg TRF

Phase 1

Healthy Volunteer | Small molecule | Other |Johnson & Johnson|Last Updated: Mar 13, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

tapentadol 25-mg TRF · 1 trial · 1 indication

Phase 1 1
NCT01273506A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 25-mg Tablets Relative to One 50-mg TabletHealthy Volunteer
COMPLETED30 Analytics
PHASE1COMPLETED
A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 25-mg Tablets Relative to One 50-mg Tablet
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Study Endpoints

Primary Endpoints

Pharmacokinetic profile, as measured by Cmax, tmax, AUC, t1/2, kel, AUMC, and MRT
two days

Secondary Endpoints

Number of participants with adverse events
time of screening to end of treatment (up to 5.5 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
001EXPERIMENTALtapentadol (CG5503) ER 25-mg TRF 50 mg TRF single oral dose
002EXPERIMENTALtapentadol (CG5503) ER 50-mg TRF 50 mg TRF single oral dose

Interventions

NameTypeDescription
tapentadol (CG5503) ER 25-mg TRFDRUG50 mg TRF single oral dose
tapentadol (CG5503) ER 50-mg TRFDRUG50 mg TRF single oral dose
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Japanese participants who have resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report * Deemed healthy on the basis of prestudy physical examination, medical history ...

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Frequently asked questions about tapentadol 25-mg TRF

What is tapentadol 25-mg TRF used for?

Tapentadol 25-mg TRF is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its bioequivalence. The drug is not approved and remains under investigation.

Who makes tapentadol 25-mg TRF?

Tapentadol 25-mg TRF is being developed by Johnson & Johnson, traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research on this small molecule drug candidate.

What phase is tapentadol 25-mg TRF in?

Tapentadol 25-mg TRF is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities.

What clinical trials is tapentadol 25-mg TRF in?

Tapentadol 25-mg TRF has one completed clinical trial, NCT01273506, which studied the bioequivalence of a 50-mg dose administered as two 25-mg tablets compared to one 50-mg tablet. The trial enrolled 30 healthy male volunteers.

Is tapentadol 25-mg TRF the same as CG5503?

Tapentadol 25-mg TRF is associated with the code name CG5503, as referenced in the clinical trial NCT01273506. The trial title mentions tapentadol (CG5503), indicating these names refer to the same drug candidate.