A Phase 1 interventional study of Brivaracetam 10 mg oral tablet and Brivaracetam 50 mg oral tablet in Healthy Volunteers, sponsored by UCB Pharma SA. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-15.
Sponsored by UCB Pharma SA · Phase 1 and Interventional
To investigate the bioavailability/bioequivalence of Brivaracetam oral tablets (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam intravenous injection (100 mg) in healthy volunteers.
UCB Pharma SA is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 10 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations. * Strength: 10 mg * Form: Oral tablet * Frequency: Once daily * Duration: 1 day
Other: Brivaracetam 10 mg oral tablet
Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 50 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations. * Strength: 50 mg * Form: Oral tablet * Frequency: Once daily * Duration: 1 day
Other: Brivaracetam 50 mg oral tablet
Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 75 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations. * Strength: 75 mg * Form: Oral tablet * Frequency: Once daily * Duration: 1 day
Other: Brivaracetam 75 mg oral tablet
Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 100 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations. * Strength: 100 mg * Form: Oral tablet * Frequency: Once daily * Duration: 1 day
Other: Brivaracetam 100 mg oral tablet
Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of 10 mL of BRV intravenous bolus injection (10 mg/mL) will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations. * Strength: 100 mg (10 mg/mL) * Form: Intravenous bolus injection * Frequency: Once daily * Duration: 1 day
Other: 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)
Maximum plasma concentration of Brivaracetam dose-normalized to the 50 mg reference treatment (Cmax)
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Area under the plasma concentration-time curve from zero to the time of the last measured concentration above the limit of quantification dose-normalized to the 50 mg reference treatment (AUC[0-t])
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Area under the plasma concentration-time curve from zero to infinity dose-normalized to the 50 mg reference treatment (AUC)
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Plasma half-life of Brivaracetam
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Time to reach the maximum plasma concentration of Brivaracetam (tmax)
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Apparent oral clearance of Brivaracetam (CL/F)
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Apparent volume of Brivaracetam distribution at the terminal elimination phase
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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UCB Pharma SA