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Tapentadol Prolonged-Release Formulation 2

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Dec 24, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02019485A Study to Assess Bioequivalence of a New Tapentadol Extended-Release Tablet With Respect to a Tapentadol Extended Release Tablet Under Fasted Conditions in Healthy SubjectsPHASE1 COMPLETED 64 — — Jul 1, 2010Aug 1, 2010Dec 24, 20131 United States
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Study Endpoints
Primary Endpoints
Maximum serum concentration of tapentadol
Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication)
Time to reach the observed maximum serum concentration of tapentadol
Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
Area under the serum concentration-time curve of tapentadol from time 0 to the time of the last quantifiable concentration
Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
Area under the serum concentration-time curve of tapentadol from time 0 to infinite time
Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
Percentage of area under the serum concentration-time curve of tapentadol from time 0 to infinite time
Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
Elimination half-life associated with the terminal slope of the semilogarithmic tapentadol concentration-time curve
Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
First-order rate constant associated with the terminal portion of tapentadol concentration curve
Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
Time to last quantifiable serum concentration of tapentadol
Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
Number of participants with adverse events
Up to end-of-study (Day 3 of last single-dose of study medication)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment Sequence ABEXPERIMENTALParticipants will receive single dose of new tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF) tablet and later, participants will receive single dose of current tapentadol prolonged-release formulation 2 (PR2) tablet without food. Administration of the study medications will be separated by a washout period (no treatment) of 7 to 14 days.
Treatment Sequence BAEXPERIMENTALParticipants will receive single dose of current tapentadol PR2 tablet and later, participants will receive single dose of new tapentadol ER TRF tablet without food. Administration of the study medication will be separated by a washout period of 7 to 14 days.
Interventions
NameTypeDescription
Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF)DRUGParticipants will receive a single dose of tapentadol ER TRF 100 mg tablet orally (by mouth) in treatment sequences AB and BA appropriately.
Tapentadol Prolonged-Release Formulation 2 (PR2)DRUGParticipants will receive a single dose of tapentadol PR2 100 mg tablet orally in treatment sequences AB and BA appropriately.
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Eligibility Criteria
Age Range19 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Agrees to protocol-defined use of effective contraception * Body mass index (BMI) between 20 and 28 kilograms per square meter, inclusive, and body weight not less than 50 kg (BMI is calculated as weight \[kilogram\] divided by square of height \[meter\]) * Habitually smokes n...

Countries:United States
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