A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects
Status:
Completed
Trial end date:
2017-08-04
Target enrollment:
Participant gender:
Summary
This study is designed to understand the relative bioavailability (proportion of the
administered dose that is absorbed into the bloodstream) of several fixed dose combinations
(FDCs) tablets of ambrisentan and tadalafil for further development and to provide
pharmacokinetic (PK - what the body does to the drug) data to enable a pivotal bioequivalence
(BE - the relationship between two preparations of the same drug in the same dosage form that
have a similar bioavailability) study. Depending on formulation work, the study will allow up
to 8 new FDCs to be compared with the reference of ambrisentan and tadalafil monotherapies.
The study will also evaluate up to 2 of the new formulations, that may be taken in to a BE
study, to be tested for any effect on pharmacokinetics of the FDC in both fed and fasted
state. This is a single centre, Phase 1, single dose, randomised, open label crossover study
with 3 study parts; each study part will have up to a 5 way crossover in healthy subjects.
Part 1 of the study will evaluate four formulations of the FDC (ambrisentan 10 milligram [mg]
+ tadalafil 40 mg) and the reference of the 2 monotherapy components taken concurrently
(ambrisentan 10 mg and tadalafil 40 mg) in the fasted stated. If successful formulations are
identified in this part of the study, then they will be re-formulated and tested in part 2.
If no successful formulations are identified in part 1 of the study, then part 2 will be
utilized to look at up to 4 new FDC formulations. However, if only two formulations, or less,
are evaluated in part 2 then the FDC formulations may be tested both fed and fasted to assess
food effect and part 3 will not be required. If successful formulations are identified in
this study part, then up to 2 of these may be tested, for food effect, in Part 3 if not
already assessed in this part. Therefore, part 3 is optional and utility is dependent on the
results of the previous study parts.