NCT01796899

A Randomized, Single-center, Open-label, 5-way Crossover, Single-dose Bioavailability/Bioequivalence Comparison of Brivaracetam Oral Tablets (10 mg, 50 mg,75 mg, and 100 mg) and Brivaracetam Intravenous Bolus Injection (100 mg) in Healthy Volunteers

Completed Phase 1 Last updated 12 April 2013

What this trial tests

Phase 1 trial testing Brivaracetam 10 mg oral tablet in Healthy Volunteers in 25 participants. Completed in 1 March 2013.

Timeline

1 January 2013

Primary endpoint
1 March 2013

1 March 2013

Quick facts

Lead sponsor	UCB Pharma SA
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Enrollment	25
Start date	1 January 2013
Primary completion	1 March 2013
Estimated completion	1 March 2013
Sites	1 location across Netherlands

Drugs / interventions tested

• Brivaracetam 10 mg oral tablet
• Brivaracetam 50 mg oral tablet
• Brivaracetam 75 mg oral tablet
• Brivaracetam 100 mg oral tablet
• 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

UCB Pharma SA — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis.
   Brandt C, Klein P, Badalamenti V, Gasalla T, et al · · 2020 · cited 30× · PMID 31937513 · DOI 10.1016/j.yebeh.2019.106864
2. Brivaracetam: Pharmacology, Clinical Efficacy, and Safety in Epilepsy.
   Hwang H, Kim WJ. · · 2025 · cited 2× · PMID 40568060 · DOI 10.14581/jer.25005
3. Abstracts Presented at the Neurocritical Care Society (NCS) 15th Annual Meeting.
   · 2017 · cited 2× · PMID 28929375 · DOI 10.1007/s12028-017-0465-9