Multiple Dose BE Study With Nevirapine 400mg PR Tablets

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Teva Pharmaceutical Industries
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Ratiopharm GmbH )
ClinicalTrials.gov Identifier:
NCT02202005
First received: July 24, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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


Condition Intervention Phase
HIV-1
Drug: Nevirapine
Drug: Viramune®
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Plasma concentrations by AUC0 τ,ss (area under the concentration time curve) [ Time Frame: Days 14, 28, 42, 56 ] [ Designated as safety issue: No ]
  • Cτ,ss (defined as concentration at the end of dosing interval) [ Time Frame: Days 14, 28, 42, 56 ] [ Designated as safety issue: No ]
  • Cmax,ss (maximum observed plasma concentration) [ Time Frame: Days 14, 28, 42, 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of fluctuation over one dosing interval at steady state (Fl(%) [ Time Frame: Days 14, 28, 42, 56 ] [ Designated as safety issue: No ]
  • Tmax,ss (the time to maximum plasma concentration at steady state) [ Time Frame: Days 14, 28, 42, 56 ] [ Designated as safety issue: No ]
  • Cmin,ss (minimum plasma concentration at steady state) [ Time Frame: Days 14, 28, 42, 56 ] [ Designated as safety issue: No ]
  • Average plasma drug concentration [ Time Frame: Days 14, 28, 42, 56 ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: August 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nevirapine Drug: Nevirapine
Nevirapine 400mg PR tablet
Drug: Viramune®
Viramune® 400 mg Retardtabletten
Active Comparator: Viramune® Drug: Nevirapine
Nevirapine 400mg PR tablet
Drug: Viramune®
Viramune® 400 mg Retardtabletten

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 neurological, endocrinal, cardiovascular, pulmonary, haematological, psychiatric, gastrointestinal, renal, hepatic, obstructive disorders, cholestasis, and metabolic disease
  5. 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)
  6. Background HIV therapy with a stable antiretroviral regimen that is recommended in combination with nevirapine according to British HIV Association clinical guidelines:

    1. Abacavir and lamivudine {ABC/3TC} as fixed dose combination Kivexa
    2. Tenofovir and emtricitabine {TDF/FTC} Truvada
    3. Zidovudine and lamivudine {AZT/3TC} - Combivir, OR
    4. Tenofovir and lamivudine as separately prescribed components and kept constant (in combination and dosage) throughout the whole course of the study
  7. An HIV viral load < 50 copies/mL in preceding 3 months and at screening
  8. A CD4+ Tcell count > 50 cell/mm3
  9. Acceptable screening laboratory values that indicate adequate baseline organ function
  10. Willingness to abstain from ingesting medications that are listed as contraindicated for nevirapine during the whole course of the study
  11. Capable of completing patient diaries
  12. Capable and willing to come back for PK assessments and follow up
  13. Willingness to refrain from excessive physical activity during the trial
  14. 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:

  1. Infection with HIV2 or HIV1 group O.
  2. Current treatment with an HIV protease inhibitor
  3. Participation in any other study within 30 days of Day 1, or intention to participate in another study during participation in this study.
  4. Male and female patients who are not willing to use male or female condoms to prevent HIV transmission
  5. Female patients of childbearing potential who:

    1. Have a positive serum pregnancy test at screening.
    2. Are breast feeding.
    3. Are planning to become pregnant
    4. Are not willing to take appropriate measures to prevent pregnancy during the study
  6. 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
  7. Laboratory parameters > DAIDS grade 2 Coagulation
  8. Laboratory parameters > DAIDS grade 2 Total triglycerides
  9. Hypersensitivity to the active substance or any ingredients of the test or reference investigational products or chemically related compounds.
  10. Contraindication to Nevirapine
  11. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion
  12. 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)
  13. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02202005

Contacts
Contact: Marta Boffito, MD MBBS 02088466507 marta.boffito@chelwest.nhs.uk

Locations
United Kingdom
Chelsea and Westminster NHS Foundation Trust Not yet recruiting
London, United Kingdom, SW10 9TH
Sponsors and Collaborators
Ratiopharm GmbH
Investigators
Principal Investigator: Teva Medical Expert, MD Chelsea and Westminster NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Ratiopharm GmbH )
ClinicalTrials.gov Identifier: NCT02202005     History of Changes
Other Study ID Numbers: NEVIR5U14EU, 2014-002247-18
Study First Received: July 24, 2014
Last Updated: July 24, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Teva Pharmaceutical Industries:
Bioequivalence

Additional relevant MeSH terms:
Nevirapine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 18, 2014