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Nevirapine

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

Nevirapine · 1 trial · 1 indication

Phase 1 1
NCT02202005Multiple Dose BE Study With Nevirapine 400mg PR TabletsHIV-1
COMPLETED46 Analytics
PHASE1COMPLETED
Multiple Dose BE Study With Nevirapine 400mg PR Tablets
HIV-1
NCT0220200546
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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 to 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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Frequently asked questions about Nevirapine

What is Nevirapine used for?

Nevirapine is a small molecule drug being studied for use in HIV-1 infection. It is an investigational drug currently in clinical development, and it is not approved for any use. The drug is being evaluated in a clinical trial to assess its effects in patients with HIV-1.

Who makes Nevirapine?

Nevirapine is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker symbol TEVA. Teva is conducting clinical research on this drug for the treatment of HIV-1 infection.

What phase is Nevirapine in?

Nevirapine is in Phase 1 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of HIV-1 infection, and its safety and efficacy are still being evaluated.

What clinical trials is Nevirapine in?

Nevirapine has one completed clinical trial, identified as NCT02202005, titled 'Multiple Dose BE Study With Nevirapine 400mg PR Tablets.' This Phase 1 study enrolled 46 participants with HIV-1 in the United Kingdom. The trial was active-controlled and included biomarker selection.

How does Nevirapine work?

Nevirapine is a small molecule drug being studied for HIV-1 infection. The specific molecular target of Nevirapine has not been disclosed in the available information, so its exact mechanism of action is not detailed here.