A randomized, open-label, two-way crossover study to assess the relative bioavailability of Laquinimod 0.6 mg test tablet versus Laquinimod 0.6 mg reference capsule after single dose administration with a single sequence extension to assess the pharmacokinetics of Laquinimod and its metabolites after single and multiple oral 0.6 mg dose administration in healthy subjects.

Laquinimod is a new investigational compound that may eventually be used for
the treatment of multiple sclerosis and Huntington*s disease.

The precise mechanism of action of laquinimod in these diseases is still under
investigation. Laquinimod appears to modify the activity of the immune system,
also within the central nervous system.

Multiple sclerosis is a chronic disease affecting the central nervous system:
the brain and spinal cord. The symptoms are caused by the body's own immune
system attacking and damaging the myelin sheaths, which are protective sheets
surrounding nerve cells. This causes inflammation within the central nervous
system disrupting communication between parts of the nervous system resulting
in physical problems (such as paralysis), mental and sometimes psychiatric
problems.

Huntington*s disease is a hereditary disease in which certain parts of the
brain are affected, which results in involuntary movements that slowly worsen,
mental deterioration and a number of psychiatric symptoms. The immune system
may play a role in Huntington*s disease.

Laquinimod is in development and is not registered as a drug but has been given
to over 3000 humans before.

The study will be performed in 2 parts, Parts 1 and 2. In Part 1, single doses
of laquinimod will be administered whereas in Part 2, multiple doses of
laquinimod will be administered. The study will be performed in a maximum of 20
healthy male and female volunteers of which 6 will participate in Part 1 only
and 14 will participate in both Parts 1 and 2.

In Part 1 of this study, 20 volunteers will receive a single dose of a tablet
formulation of laquinimod and a single dose of a capsule formulation of
laquinimod in 2 separate treatment periods (Periods 1 and 2). It will be
investigated how quickly and to what extent laquinimod is absorbed and
eliminated from the body (this is called pharmacokinetics). Also, the
pharmacokinetics of laquinimod will be compared between the single dose tablet
and capsule formulations; this is called relative bioavailability.

In Part 2 of this study, 14 volunteers will receive a laquinimod capsule once
daily for 14 days after which pharmacokinetics of multiple laquinimod dosing
can be determined.

In addition, it will be investigated to what extent single (Part 1) and
multiple (Part 2) doses of laquinimod are tolerated.

Part 1 of the study will consist of 2 periods (Periods 1 and 2).
During Period 1 the volunteers will stay in the clinical research center for 5
days (4 nights): from the afternoon of Day -1 (1 day before administration of
the study compound; also called admission) to the morning of Day 4 (Day 1 is
the day of administration of the study compound).

In Period 1, they are expected at the clinical research center on Day -1 at
14:00 h in the afternoon. 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).

In Period 1, they will receive a single dose of either 0.6 milligrams (mg)
laquinimod as an oral tablet or 0.6 mg laquinimod as an oral capsule on Day 1.
They will leave the clinical research center on Day 4 of Period 1.

If they have received the laquinimod capsule in Period 1, they will have to
return to the clinical research center in the morning of Days 6, 8 and 12 so
that a blood sample can be collected.

The time interval between dosing in Periods 1 and 2 is at least 20 days.

During Period 2 the volunteers will stay in the clinical research center for 19
days (18 nights): from the afternoon of Day -1 (1 day before first
administration of the study compound [Day 1]; also called admission) to the
morning of Day 18.

In Period 2, the are expected at the clinical research center on Day -1 at
14:00 h in the afternoon.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).

In Period 2, they will receive a single dose of either 0.6 milligrams (mg)
laquinimod as an oral tablet or 0.6 mg laquinimod as an oral capsule on Day 1.
From Day 4 to Day 17 (please note that this is actually Part 2 of the study),
they will receive a laquinimod capsule of 0.6 mg once daily for 14 days.

They will leave the clinical research center on Day 18 of Period 2.

The volunteers will have to return to the clinical research center in the
morning of Days 19, 20, 22, 24 and 30 so that a blood sample can be collected;
they will be informed at what time you will be expected at the clinical
research center on these days.

The follow-up visit will take place 17 to 21 days after they have left the
clinical research center on Day 18 of Period 2 (Day 37 ± 2 days). The
appointment for the follow-up visit will be made during the study.

The participation to the entire study, from pre-study screening until the
follow-up visit, will be a maximum of 85 days.

Period 1: Day 1 : 0,6 mg laquinimod
Period 2: Day 1 : 0,6 mg laquinimod and Day 4 t/m 17 once daily 0,6 mg
laquinimod.

Pain, minor bleedings, bruises, possibly an infection.