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.

Summary

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.

Test preparation A(T1): Brivaracetam sustained-release tablets (100mg/ tablet, developed by Taizhou Overseas Pharmaceuticals Co.,Ltd.) Test preparation B(T2): Brivaracetam sustained-release tablets (50mg/ tablet, developed by Taizhou Overseas Pharmaceuticals Co.,Ltd.) Reference preparation (R): Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB) Objective: The sustained-release tablets of Brivaracetam (specification: 100mg) developed by Taizhou Overseas Pharmaceuticals Co.,Ltd. were used as the test preparation A(T1), the sustained-release tablets of Brivaracetam (specification: 50mg) were used as the test preparation B(T2), and the Brivaracetam tablets (trade name: BRIVIACT®, specification: 50mg) produced by UCB were used as the reference preparation (R). To compare the blood concentration and main pharmacokinetic parameters between test preparation A(T1) and test preparation B(T2), between test preparation A(T1) and reference preparation, and between test preparation B(T2) and reference preparation, and evaluate the relative bioavailability and sustained release characteristics of test preparation.

Objective: To evaluate the safety of China healthy volunteers after oral administration of sustained-release tablets of test preparation A(T1) and B(T2) and reference preparation (R) Brivaracetam tablets on an empty stomach.

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.

Sponsors & Collaborators

• GX pharma technology (beijing) Co., Ltd

  collaborator UNKNOWN

• Overseas Pharmaceuticals, Ltd.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-13

Primary Completion

2023-03-30

Completion

2023-03-30

FDA Drug

Yes

Countries

• China

Study Locations