An Open Label, Balanced, Randomized, 3×3 Latin Square Design Comparing of Brivaracetam Sustained-release Tablets and Brivaracetam Tablets in the Oral Comparative Pharmacokinetic(PK) Study in Chinese Healthy Adult Subjects Under Fasting Conditions.

PHASE1UnknownINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 13, 2022

Primary Completion Date

March 30, 2023

Study Completion Date

March 30, 2023

Conditions
Partial Seizure
Interventions
DRUG

Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB)

"Brivaracetam tablets (trade name: Briviact) Specification: 50mg/ piece Batch number: 34244 Content: 100.0% Date of purchase: September 2022~According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach.~Expiry date: April 2025 Storage conditions: sealed, stored at 20-25℃, allowing short-term temperature deviation of 15-30℃ Manufacturer: Union Chimique Belge Pharm, UCB Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd."

DRUG

Brivaracetam sustained-release tablets 100mg

"Brivaracetam sustained-release tablets Specification: 100mg/ tablet Batch number: 22081201 Content: 102.5% Date of production: August 12, 2022 Expiry date: August 11th, 2024. Storage conditions: sealed and stored at 10-30℃ Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd.~According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach."

DRUG

Brivaracetam sustained-release tablets 50mg

"Brivaracetam sustained-release tablets Specification: 50mg/ piece Batch number: 22082501 Content: 100.0% Date of production: September 02, 2022 Expiry date: August 24th, 2024. Storage conditions: sealed and stored at 10-30℃ Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd.~According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach."

Trial Locations (1)

300121

Tianjin Municipal People's Hospital, Tianjin

Sponsors
All Listed Sponsors
collaborator

GX pharma technology (beijing) Co., Ltd

UNKNOWN

lead

Overseas Pharmaceuticals, Ltd.

INDUSTRY

NCT05622370 - An Open Label, Balanced, Randomized, 3×3 Latin Square Design Comparing of Brivaracetam Sustained-release Tablets and Brivaracetam Tablets in the Oral Comparative Pharmacokinetic(PK) Study in Chinese Healthy Adult Subjects Under Fasting Conditions. | Biotech Hunter | Biotech Hunter