NCT02688387 - A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects | Biotech Hunter

Enrollment

112

Participants

Timeline

Start Date

March 18, 2016

Primary Completion Date

August 4, 2017

Study Completion Date

August 4, 2017

Conditions

Hypertension, Pulmonary

Interventions

DRUG

FDC (ambrisentan 10 mg-tadalafil 40 mg) single dose

The four FDCs in part 1 will have the following formulation designation: FDC1, FDC2, FDC3 and FDC4. They are film-coated tablets. The dose will be administered orally. Study treatment for Part2 and Part 3 will be amended after Part 1 study

DRUG

Reference (ambrisentan 10 mg + tadalafil 40 mg given concurrently)

Ambrisentan is a film-coated tablet. Each tablet of ambrisentan contains 10 mg of ambrisentan, approximately 95 mg of lactose (as monohydrate), 0.25 mg of lecithin and 0.11 mg of Allura red AC Aluminium Lake. Tadalafil is also a film-coated tablet. Each tablet of Tadalafil contains 20 mg tadalafil and 233 mg lactose. Both the tablets will be administered orally concurrently.

Trial Locations (1)

NW10 7EW

GSK Investigational Site, London