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Nevirapine

Phase 1

HIV-1 | Small molecule | Infectious Disease |Teva Pharmaceutical Industries Limited|Last Updated: Aug 25, 2015

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
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02202005Multiple Dose BE Study With Nevirapine 400mg PR TabletsPHASE1 COMPLETED 46Aug 1, 2014Aug 1, 2015Aug 25, 20151 United Kingdom
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Study Endpoints
Primary Endpoints
Plasma concentrations by AUC0 τ,ss (area under the concentration time curve)
Days 14, 28, 42, 56
Cτ,ss (defined as concentration at the end of dosing interval)
Days 14, 28, 42, 56
Cmax,ss (maximum observed plasma concentration)
Days 14, 28, 42, 56
Secondary Endpoints
Percentage of fluctuation over one dosing interval at steady state (Fl(%)
Days 14, 28, 42, 56
Tmax,ss (the time to maximum plasma concentration at steady state)
Days 14, 28, 42, 56
Cmin,ss (minimum plasma concentration at steady state)
Days 14, 28, 42, 56
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
NevirapineEXPERIMENTAL -
Viramune®ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
NevirapineDRUGNevirapine 400mg PR tablet
Viramune®DRUGViramune® 400 mg Retardtabletten
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Signed and dated written informed consent prior to admission to the study 2. HIV1 infected males or females of 18 to 65 years, nonsmoker (use of cannabis may be accepted) 3. Body weight ≥ 50.0 kg and BMI ≥ 18.0 and ≤ 32.0 kg/m2 4. Absence of clinically significant history of ...

Countries:United Kingdom
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