Overview

Bioequivalence Study of CRushed TriUMeq With or Without Drip Feed Compared to the Whole Tablet

Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
Dolutegravir is an HIV-1 integrase inhibitor which is marketed as a single tablet (Tivicay®) and in a fixed dose combination tablet with abacavir and lamivudine (Triumeq®, referred to as TRI). For patients with swallowing difficulties, administration of whole tablets can be problematic and tablets are cut or crushed to ease administration. Currently there is no information about crushing TRI tablets. Therefore this study will be conducted to investigate whether crushed and suspended TRI and crushed and suspended TRI with drip feed are bioequivalent to taking TRI as a whole.
Phase:
Phase 1
Details
Lead Sponsor:
Radboud University
Treatments:
Abacavir
Dolutegravir
Lamivudine
Triumeq