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.
Completed
- Conditions
- Huntington's Disease and Multiple Sclerose10007951
- Registration Number
- NL-OMON43112
- Lead Sponsor
- Teva Pharmaceutical Industries, Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to assess the relative bioavailability<br /><br>of 2 formulations of laquinimod, a test formulation of 0.6 mg tablet and a<br /><br>reference formulation of 0.6 mg capsule, in healthy subjects, after a single<br /><br>dose administration in fasted conditions.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the pharmacokinetics of laquinimod and 5 of its metabolites (DELAQ,<br /><br>6-HLAQ, 8-HLAQ, Spiro-LAQ, and DCLAQ) after a 0.6 mg oral administration of<br /><br>laquinimod capsule as a single dose and at steady state.<br /><br><br /><br>To determine the safety and tolerability of 2 formulations of laquinimod 0.6 mg<br /><br>in healthy subjects.</p><br>