Bioequivalence Study of Two Brivaracetam Oral Solutions in Healthy Adults Under Fasting and High-Fat Meal Conditions

PHASE1Enrolling by invitationINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 21, 2024

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Epilepsy (treatment Refractory)
Interventions
DRUG

Brivaracetam Oral Solution (Test Formulation)

The drug is manufactured by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. The formulation is provided as a 300 mL: 3 g solution, with a dosage of 10 mL (100 mg) per single oral dose. The drug will be administered to participants in the fasting group during the first phase of the study and to participants in the high-fat meal group during the second phase of the study.

DRUG

Brivaracetam Oral Solution (Reference Formulation)

The drug is manufactured by UCB Pharma S.A. under the trade name Briviact®. The formulation is provided as a 300 mL: 3 g solution, with a dosage of 10 mL (100 mg) per single oral dose. The drug will be administered to participants in the fasting group during the first phase of the study and to participants in the high-fat meal group during the second phase of the study.

Trial Locations (1)

210033

Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing

All Listed Sponsors
collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

lead

Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

INDUSTRY