The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate
Status:
Completed
Trial end date:
2017-01-21
Target enrollment:
Participant gender:
Summary
A Phase 2, open-label, randomized, cross-over, pharmacokinetic study designed to determine
the effect of meals of various amounts of fat given immediately prior to dosing on the
pharmacokinetics of oral testosterone undecanoate. Approximately 20 hypogonadal subjects will
be dosed for a 14 day run-in period. This will be followed by a randomized sequence of five
periods over a 6 day confinement period. Subjects will receive a randomly ordered sequence of
breakfast meals containing various amounts of fat, fasting, 15 g, 30 g, 45 g and a high fat
breakfast consistent Guidance for Industry on Food-Effect Bioavailability and Fed
Bioequivalence Studies.