A RANDOMIZED, SINGLE-CENTER, OPEN-LABEL, 5-WAY CROSSOVER, SINGLE-DOSE BIOAVAILABILITY/BIOEQUIVALENCE COMPARISON OF BRIVARACETAM ORAL TABLETS (10MG, 50MG, 75MG, AND 100MG) AND BRIVARACETAM INTRAVENOUS BOLUS INJECTION (100MG) IN HEALTHY VOLUNTEERS

A RANDOMIZED, SINGLE-CENTER, OPEN-LABEL, 5-WAY CROSSOVER, SINGLE-DOSE BIOAVAILABILITY/BIOEQUIVALENCE COMPARISON OF BRIVARACETAM ORAL TABLETS (10MG, 50MG, 75MG, AND 100MG) AND BRIVARACETAM INTRAVENOUS BOLUS INJECTION (100MG) IN HEALTHY VOLUNTEERS - Brivaracetam BA/BE study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38511

Enrollment

Registered

2013-01-17

Start date

2013-01-29

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

attacks epileptic seizures

Interventions

Strength: Tablets of 10, 50, 75 and 100 mg

100mg iv bolus 10mg/mL injection Dosage form: Oral Tablets of 10, 50, 75 and 100 mg

100mg iv bolus 10mg/mL injection using a syringe and slow push in 2 minutes The order in which the treatments are given in the 5 periods may differ between volunteers.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy males and females 18-55 years, incl. BMI 18.0-30.0 kg/m2 incl.

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
Pharmacokinetics: plasma drug concentrations, pharmacokinetic parameters Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination.	—

Secondary

Measure	Time frame
Pharmakinetics parameters: analysis of variance on Cmax and AUC, other parameters descriptive statistics. Safety parameters: descriptive statistics.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)