Multiple dose BE study with Nevirapine 400mg PR tablets - Version 1.0
Research type
Research Study
Full title
A multiple dose, open label, pivotal, 4- period, 2-treatment, 2-sequence full replicative cross-over 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® 400mg prolonged-release tablets under fasted conditions in HIV-1 infected patients
IRAS ID
158310
Contact name
Marta Boffito
Contact email
Sponsor organisation
ratiopharm GmbH
Eudract number
2014-002247-18
Research summary
The antiretroviral drug Nevirapine, used to treat HIV, is marketed under the trade name Viramune® by the drug company Boehringer Ingelheim (BI). Until recently, BI were the only company allowed to make nevirapine due to patenting laws, As soon as the patent expires other companies may launch other medication using Nevirapine to the market. These versions of the drugs are called “generics” to distinguish them from the original marketed drug Viramune® made by BI.
To ensure that the generic versions of a medicine – called the TEST drug - is of the same quality as the original – the REFERENCE drug, - the company making it needs to show that certain key characteristics of the generic medicine are similar enough to the original medicine. One of these key characteristics is Bioequivalence – this means that when the same dose is taken of the REFERENCE and the TEST drug, that the same active compound of the medicine is absorbed and distributed throughout the body via the bloodstream, at the same levels and for the same time after being taken.
The purpose of this study is to test a generic version of Nevirapine, manufactured by the company Teva Pharmaceutical Works Private Limited Company, Hungary, to show that it is equivalent as described above to Viramune® 400mg prolonged release tablets as the REFERENCE product.
If participants decide to take part, the duration of their involvement in the study will be 57 days for the main part of the study. In addition there will be a period of time of up to 42 days after a screening visit, prior to entering the study. This period is used to determine whether the participant's fulfil the criteria required for entry in to the study. There will be a follow-up visit approximately 14 days after completion of the study to assess the participant's health
REC name
London - Central Research Ethics Committee
REC reference
14/LO/1288
Date of REC Opinion
7 Aug 2014
REC opinion
Favourable Opinion