Comparing tablets containing ambrisentan and tadalafil; v1
Research type
Research Study
Full title
A Phase 1 study to demonstrate the relative bioavailability and bioequivalence of fixed dose combinations of ambrisentan and tadalfil in healthy subjects\n(HMR code: 15-008) \n
IRAS ID
199025
Contact name
Adeep Puri
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2015-004140-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Pulmonary arterial hypertension (PAH) is an increase in blood pressure in the blood vessels that carry blood from the heart to the lungs. Ambrisentan and tadalafil (the study medicines) are currently used to treat PAH. They work by relaxing and widening the blood vessels so blood can flow through them more quickly. Studies show that the study medicines work better when taken together, so PAH patients often take them together, in separate tablets. But, it would be more convenient for patients if ambrisentan and tadalafil were available as a single combined tablet. We hope that if the study medicines are taken as a single combined tablet they will work just as well or better than separate tablets.\n\nIn this up to 3-part study, we’ll test up to 8 different forms of ‘combined’ tablets of the study medicines to find out their blood levels and side effects. We’ll also test whether food affects blood levels of the study medicines.\n\nIn each part, we’ll give up to 20 healthy volunteers, aged 18–60, up to 5 single doses of the study medicines by mouth, either as separate tablets or combined as 1 tablet. In Part 1, doses will be given after an overnight fast; in Parts 2 and 3, they’ll be given either after an overnight fast or after a fatty breakfast. \n\nParticipants may take up to 11 weeks to finish one part of the study. In each part, they’ll make up to 8 outpatient visits, and stay on the ward up to 5 times, for 3 nights in a row each time. Participants who complete Part 2, may be invited back to do Part 3.\n\nA pharmaceutical company, GlaxoSmithKline, is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/0060
Date of REC Opinion
1 Feb 2016
REC opinion
Favourable Opinion