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.

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. - Bioavailability study Laquinimod test tablets

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43112

Enrollment

Registered

2016-10-31

Start date

2016-10-05

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington's Disease and Multiple Sclerose

Interventions

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.

Huntington's disease

Laquinimod

Multiple sclerose

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male or female 18 - 45 years of age, inclusive BMI 18.5 - 29.9 kilograms/meter2, inclusive body weight 50 kilograms or higher non-smoking

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to assess the relative bioavailability of 2 formulations of laquinimod, a test formulation of 0.6 mg tablet and a reference formulation of 0.6 mg capsule, in healthy subjects, after a single dose administration in fasted conditions.	—

Secondary

Measure	Time frame
To assess the pharmacokinetics of laquinimod and 5 of its metabolites (DELAQ, 6-HLAQ, 8-HLAQ, Spiro-LAQ, and DCLAQ) after a 0.6 mg oral administration of laquinimod capsule as a single dose and at steady state. To determine the safety and tolerability of 2 formulations of laquinimod 0.6 mg in healthy subjects.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)