Pharmacokinetics Clinical Trial
Official title:
PK Study of Oral Rivaroxaban in Healthy Subjects
The primary objective of this study is to learn about the relative bioavailability (the extent to which the drug becomes available to the body) and pharmacokinetics (blood levels) of rivaroxaban in healthy participants after receiving a 20 mg rivaroxaban tablet orally as a whole tablet, crushed and mixed in applesauce, and as a suspension through a Naso-gastric (NG) tube. The relative bioavailability of rivaroxaban may be different when given as a crushed tablet compared with an intact (whole) tablet and when given via an NG tube. The safety and tolerability of rivaroxaban will also be assessed.
This is a single-center, open-label (all people know the identity of the drug), randomized
(the study drug is assigned by chance), 3-period, 3-treatment cross over study of the
relative bioavailability (the extent to which the drug becomes available to the body) of
single dose rivaroxaban given to healthy participants in 3 ways. All participants will be
randomly assigned to follow 1 of 6 possible ordered sequences whereby they ultimately
receive rivaroxaban as: a whole tablet orally (Treatment A), a crushed tablet mixed in
applesauce orally (Treatment B), and a crushed tablet in a water suspension administered via
NG tube (Treatment C). Each rivaroxaban treatment will be taken with food (a standardized
liquid meal).
Participants will be randomly assigned into one of the following 6 sequences:
- Sequence 1: Treatment A - Treatment B - Treatment C
- Sequence 2: Treatment A - Treatment C - Treatment B
- Sequence 3: Treatment B - Treatment C - Treatment A
- Sequence 4: Treatment B - Treatment A - Treatment C
- Sequence 5: Treatment C - Treatment A - Treatment B
- Sequence 6: Treatment C - Treatment B - Treatment A.
It is expected that a total of 9 participants will be randomly assigned into each sequence.
Each single-dose treatment period will be followed by a washout period (period when
receiving no treatment) of sufficient length to ensure absence of drug carry over from one
treatment period to the next.
The study will enroll approximately 54 participants to achieve 42 completed participants.
The study will consist of a screening phase (no longer than 21 days before entering the
clinical research facility on the day before starting the study drug), randomly assigned to
1 of 6 sequences, and an open-label treatment phase consisting of 3 treatment periods (4
days for each treatment) separated by a washout period of 6-14 days between rivaroxaban
administrations in each treatment periods.
Participants will be admitted to the study unit in the morning of the day before the giving
of the first dose of study drug (Day -1). Study drug will be given in the morning of the
first day of each treatment period (Day 1), followed by a standard Osmolite® 1.5 Cal (Abbott
Laboratories) liquid meal.
Participants will receive study drug in the morning and Osmolite® 1.5 Cal will be given as
the breakfast meal. Osmolite® 1.5 Cal is a standardized source of balanced nutrition for
patients requiring low-residue meals via a feeding tube or orally and/or who may have
limited volume tolerance or fluid restrictions. An Osmolite® 1.5 Cal meal includes 1.5
calories/mL overall, and 62.7 g of protein/L. Participants can have a regular meal 3 or more
hours after the Osmolite® 1.5 Cal meal.
Each treatment period will be followed by a 6 to 14 day washout period. The washout period
will start after the giving of study drug.
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