An open-label, randomized, crossover study to evaluate the pharmacokinetics, bioavailability, and bioequivalence following administration of JZP-507 oral solution and Xyrem®in healthy subjects.

JZP-507 oral solution is a new investigational compound that may eventually be
used for the treatment of narcolepsy. Narcolepsy is a sleeping disorder that
involves excessive daytime sleepiness and, in some people, a sudden loss of
muscle tone usually triggered by strong emotion
(cataplexy). One of the current medications for excessive daytime sleepiness
and cataplexy in narcolepsy is Xyrem® (sodium oxybate, also known as the sodium
salt of gamma-hydroxybutyric acid [GHB]). Sodium oxybate/GHB is a substance
that has depressant or sedating effects in
people. Xyrem® is an oral solution that contains a high amount of sodium when
given at the highest approved dose. JZP-507 contains the same active molecule
or substance (oxybate) as Xyrem®, but contains less sodium to reduce the daily
intake of sodium during treatment. JZP-507
is in development and is not registered as a drug but has been given to humans
before.

The purpose of the study is to investigate how quickly and to what extent
JZP-507 is absorbed and eliminated from the body (this is called
pharmacokinetics). This will be compared to the pharmacokinetics of Xyrem®. If
the results show that the pharmacokinetics of JZP-507 and Xyrem® are
comparable, they will be considered *bioequivalent*. In addition, the effect of
food on the pharmacokinetics of JZP-507 will be investigated. The safety and
tolerability of JZP-507 and Xyrem® will also be carefully monitored during the
study. In this study, each volunteer will receive JZP-507 as well as Xyrem® to
be able to compare results within each volunteer. This study will be performed
in up to 60 healthy male and female volunteers.

Day 1 is the first day of administration of study compound (JZP-507 or Xyrem®).
The volunteers are expected at the clinical research center at 14:00 h in the
afternoon prior to the day of first administration of the study compound. They
will be required not to have consumed any food or drinks during the 4 hours
prior to arrival in the clinical research center (with the exception of water).

Each administration of study compound is separated by a period of 1 day. The
volunteers will receive JZP-507 or Xyrem® on Days 1, 3 and 5. During the study
they will stay in the clinical research center for 7 days (6 nights: from Day
-1 to Day 6). On the final study day (Day 6) they will undergo a post-study
screening, during which they will be subjected to similar examinations as
during the pre-study screening. I
f the participation in the study is ended earlier than Day 6 for any reason,
they will be asked to undergo the post-study evaluations to check on their
safety and to complete any final tests. They will leave the clinical research
center on Day 6. The participation in the entire study, from the pre-study
screening until the post-study screening, will be a maximum of 27 days.

Treatment A: 9 milliliters JZP-507 (equivalent to 4.5 grams sodium oxybate), no
food, once.
Treatment B: 9 milliliters JZP-507 (equivalent to 4.5 grams sodium oxybate),
with food, once.
Treatment C: 9 milliliters Xyrem® (equivalent to 4.5 grams sodium oxybate), no
food, once.

Pain, minor bleedings, bruises, possibly an infection.