- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02202005
Multiple Dose BE Study With Nevirapine 400mg PR Tablets
August 21, 2015 updated by: Ratiopharm GmbH
A Multiple Dose, Open Label, Pivotal, 4 Period, 2 Treatment, Sequence Full Replicative Crossover Study to Assess the Bioequivalence (BE) of TEVA's Generic Once Daily Nevirapine 400 mg Prolonged Release (PR) Formulation Compared With the Approved Reference Product Viramune® 400 mg Prolonged Release Tablets Under Fasted Conditions in HIV1 Infected Patients
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, SW10 9TH
- Chelsea and Westminster NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Capable and willing to come back for PK assessments and follow up
- Willingness to refrain from excessive physical activity during the trial
- Willingness of male study participants to not father a child during and throughout the study. To prevent a pregnancy of the female partner, both the male study participant and the female partner need to take appropriate contraceptives to prevent pregnancy during the study.
Exclusion Criteria:
- 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
- Use of concomitant medication (other than the stable background antiretroviral HIV therapy) that may interfere with the pharmacokinetics of nevirapine and/or the background antiretroviral HIV therapy)
- Intake of products containing St. John's Wort from 14 days before treatment with study medication (Day 1) and not willing to abstain from it throughout the study until after the last study visit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nevirapine
|
Nevirapine 400mg PR tablet
Viramune® 400 mg Retardtabletten
|
Active Comparator: Viramune®
|
Nevirapine 400mg PR tablet
Viramune® 400 mg Retardtabletten
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentrations by AUC0 τ,ss (area under the concentration time curve)
Time Frame: Days 14, 28, 42, 56
|
Days 14, 28, 42, 56
|
Cτ,ss (defined as concentration at the end of dosing interval)
Time Frame: Days 14, 28, 42, 56
|
Days 14, 28, 42, 56
|
Cmax,ss (maximum observed plasma concentration)
Time Frame: Days 14, 28, 42, 56
|
Days 14, 28, 42, 56
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of fluctuation over one dosing interval at steady state (Fl(%)
Time Frame: Days 14, 28, 42, 56
|
Days 14, 28, 42, 56
|
Tmax,ss (the time to maximum plasma concentration at steady state)
Time Frame: Days 14, 28, 42, 56
|
Days 14, 28, 42, 56
|
Cmin,ss (minimum plasma concentration at steady state)
Time Frame: Days 14, 28, 42, 56
|
Days 14, 28, 42, 56
|
Average plasma drug concentration
Time Frame: Days 14, 28, 42, 56
|
Days 14, 28, 42, 56
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Teva Medical Expert, MD, Chelsea and Westminster NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
July 24, 2014
First Submitted That Met QC Criteria
July 24, 2014
First Posted (Estimate)
July 28, 2014
Study Record Updates
Last Update Posted (Estimate)
August 25, 2015
Last Update Submitted That Met QC Criteria
August 21, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEVIR5U14EU
- 2014-002247-18 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV-1
-
Helios SaludViiV HealthcareUnknownHiv | HIV-1-infectionArgentina
-
ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University... and other collaboratorsCompletedHIV-1Burkina Faso, Zambia
-
Hospital Universitari Vall d'Hebron Research InstituteGilead SciencesCompleted
-
Hospital Universitari Vall d'Hebron Research InstituteUniversity Hospital, Ghent; IrsiCaixaCompleted
-
Gilead SciencesCompleted
-
University of AarhusAarhus University Hospital Skejby; Bandim Health Project; Abbott; Ministry of Health...Completed
-
Tibotec Pharmaceuticals, IrelandCompletedHIV-1United States, France, Spain, Portugal, Canada, United Kingdom, South Africa, Argentina, Brazil, Puerto Rico, Thailand, Netherlands, Romania
-
Tibotec Pharmaceuticals, IrelandCompletedHIV-1United States, Canada, France, Belgium, Germany, Spain, Argentina, Chile, Panama, Brazil, Puerto Rico, Thailand, Mexico, Australia
-
Mymetics CorporationInstitut Cochin; San Raffaele University Hospital, Italy; Kinesis Pharma B.V.; ... and other collaboratorsCompleted
-
Janssen Pharmaceutica N.V., BelgiumCompleted
Clinical Trials on Nevirapine
-
Boehringer IngelheimCompletedHIV InfectionsUnited States, Botswana, Germany, South Africa
-
Boehringer IngelheimCompletedHIV InfectionsUnited States, France, Germany, United Kingdom
-
Boehringer IngelheimCompletedHIV InfectionsUnited States, Argentina, Australia, Belgium, Botswana, Canada, France, Germany, Ireland, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Switzerland, United Kingdom
-
Boehringer IngelheimCompleted
-
Peking Union Medical CollegeMinistry of Science and Technology of the People´s Republic of ChinaCompleted
-
Boehringer IngelheimCompleted
-
Makerere UniversityUniversity of LiverpoolCompletedHIV Infections | TuberculosisUganda
-
Boehringer IngelheimCompletedHIV InfectionsArgentina, Germany, Italy, Mexico, Poland, Portugal, Romania, Spain, Switzerland, United Kingdom
-
Elim Pediatric Pharmaceuticals Inc.Unknown