Multiple Dose BE Study With Nevirapine 400mg PR Tablets

NCT02202005 | Completed Phase 1

• 2 other identifiers: NEVIR5U14EU2014-002247-18
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this steady state pivotal study is to compare the rate and extent of absorption and to evaluate Bioequivalence of test drug compared to the approved reference product in HIV infected individuals

Conditions

HIV-1

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

• Average plasma drug concentration

  Days 14, 28, 42, 56

Study Arms (2)

Nevirapine

EXPERIMENTAL

Drug: Nevirapine; Drug: Viramune®

Viramune®

ACTIVE COMPARATOR

Drug: Nevirapine; Drug: Viramune®

Interventions

Nevirapine DRUG

Nevirapine 400mg PR tablet

Nevirapine; Viramune®

Viramune® DRUG

Viramune® 400 mg Retardtabletten

Nevirapine; Viramune®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent prior to admission to the study
• HIV1 infected males or females of 18 to 65 years, nonsmoker (use of cannabis may be accepted)
• Body weight ≥ 50.0 kg and BMI ≥ 18.0 and ≤ 32.0 kg/m2
• Absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, haematological, psychiatric, gastrointestinal, renal, hepatic, obstructive disorders, cholestasis, and metabolic disease
• Treatment with a stable nevirapine based combination regimen for at least the preceding 12 weeks (or 6 weeks if switched from an antiretroviral regimen containing two nucleoside analogues and efavirenz)
• Background HIV therapy with a stable antiretroviral regimen that is recommended in combination with nevirapine according to British HIV Association clinical guidelines:
• Abacavir and lamivudine {ABC/3TC} as fixed dose combination Kivexa
• Tenofovir and emtricitabine {TDF/FTC} Truvada
• Zidovudine and lamivudine {AZT/3TC} - Combivir, OR
• Tenofovir and lamivudine as separately prescribed components and kept constant (in combination and dosage) throughout the whole course of the study
• An HIV viral load \< 50 copies/mL in preceding 3 months and at screening
• A CD4+ Tcell count \> 50 cell/mm3
• Acceptable screening laboratory values that indicate adequate baseline organ function
• Willingness to abstain from ingesting medications that are listed as contraindicated for nevirapine during the whole course of the study
• Capable of completing patient diaries

You may not qualify if:

• Infection with HIV2 or HIV1 group O.
• Current treatment with an HIV protease inhibitor
• Participation in any other study within 30 days of Day 1, or intention to participate in another study during participation in this study.
• Male and female patients who are not willing to use male or female condoms to prevent HIV transmission
• Female patients of childbearing potential who:
• Have a positive serum pregnancy test at screening.
• Are breast feeding.
• Are planning to become pregnant
• Are not willing to take appropriate measures to prevent pregnancy during the study
• Females who do not use an acceptable contraceptive regimen or confirm total abstinence will be allowed to participate in this study only if they are not considered to be of childbearing potential
• Laboratory parameters \> DAIDS grade 2 Coagulation
• Laboratory parameters \> DAIDS grade 2 Total triglycerides
• Hypersensitivity to the active substance or any ingredients of the test or reference investigational products or chemically related compounds.
• Contraindication to Nevirapine
• Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion

Sponsors & Collaborators

• Ratiopharm GmbH: lead

Study Sites (1)

Chelsea and Westminster NHS Foundation Trust

London, SW10 9TH, United Kingdom

Location

MeSH Terms

Interventions

Nevirapine

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Teva Medical Expert, MD

  Chelsea and Westminster NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 28, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 25, 2015

Record last verified: 2015-08

Locations

GB (1)