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.

NCT05622370 | Unknown Phase 1 FDA Drug

• 1 other identifier: GXPH-BLXTHSP-YPK
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Epilepsy; 16 years old and above; brivaracetam

Outcome Measures

Primary Outcomes (3)

• Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last)

  The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-last within \[0.8, 1.25\] range will be used to determine the result of bioequivalence.

  1 month

• Area under the curve from time zero to infinity (AUC0-inf)

  The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of AUC0-inf within \[0.8, 1.25\] range will be used to determine the result of bioequivalence.

  1 month

• Peak concentration at each treatment period (Cmax,tp)

  The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of Cmax,tp within \[0.8, 1.25\] range will be used to determine the result of bioequivalence.

  1 month

Secondary Outcomes (4)

• Peak concentration of the first dosing (Cmax)

  1 month

• Time to reach peak concentration of the first dosing (Tmax)

  1 month

• Terminal half-life (T1/2)

  1 month

• Mean residence time (MRT)

  1 month

Study Arms (3)

Brivaracetam sustained-release tablets 100mg

EXPERIMENTAL

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 tablets (50mg/ tablet, BRIVIACT®, UCB); Drug: Brivaracetam sustained-release tablets 50mg

Brivaracetam sustained-release tablets 50mg

EXPERIMENTAL

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.

Drug: Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB); Drug: Brivaracetam sustained-release tablets 100mg

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

ACTIVE COMPARATOR

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; Drug: Brivaracetam sustained-release tablets 50mg

Interventions

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

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.

Brivaracetam sustained-release tablets 100mg; Brivaracetam sustained-release tablets 50mg

Brivaracetam sustained-release tablets 100mg DRUG

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.

Brivaracetam sustained-release tablets 50mg; Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB)

Brivaracetam sustained-release tablets 50mg DRUG

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.

Brivaracetam sustained-release tablets 100mg; Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects fully understand the purpose, nature, methods and possible adverse reactions of the experiment, volunteer as subjects, and sign an informed consent form before any research procedure starts;
• Male and female subjects aged from 18 to 60 years (including 18 and 60 years);
• Male weight ≥50.0 kg, female weight ≥45.0 kg, body mass index (BMI) in the range of 19.0\~26.0 kg/m2 (including the critical value);
• The subject has no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, blood and lymph, endocrine, immune, mental, nervous, gastrointestinal system, etc., and is in good general health;
• During screening, vital signs examination, physical examination, clinical laboratory examination (blood routine examination, urine routine examination, blood biochemistry examination, hepatitis B, hepatitis C, AIDS and syphilis examination, coagulation function), pregnancy examination (only for women), chest X-ray examination, 12-lead electrocardiogram and nicotine examination, the results show that there is no abnormality or no clinical significance;
• Subjects (including male subjects) have no pregnancy plans and voluntarily take effective contraceptive measures from two weeks before the screening date to six months after the last administration, and have no plans for sperm donation or egg donation; Female subjects/male subjects and their female partners of childbearing age did not have unprotected sex within one month before the screening, and female subjects agreed not to use contraceptives from the screening to the end of the trial;
• Subjects can communicate well with researchers, and understand and abide by the requirements of this research.

You may not qualify if:

• those who have a history of allergy to research drugs or their adjuvants, or are allergic to drugs, food, pollen or have a specific history of allergy (asthma, allergic rhinitis, eczema), etc.;
• Have a history of dysphagia or any gastrointestinal diseases that affect drug absorption;
• Anyone who has a history of surgery or trauma that may affect the safety of the trial or the in vivo process of the drug, or who plans to have surgery during the study period;
• Any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health products were taken orally within 28 days before the screening, especially any drugs that change the activity of liver enzymes (such as: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoid, omeprazole; Inhibitors--SSRI antidepressants, cimetidine, diltiazem macrocyclic lipids, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines, etc.);
• Screening those who have a history of drug abuse within 6 months before;
• Screening those who have used drugs within the first 3 months;
• Screening those who have been vaccinated within 2 months before screening;
• Those who smoke more than 5 cigarettes per day within 3 months before screening, or can't stop using any tobacco products during the trial period;
• Drinking more than 14 units per week (1 unit = 17.7 mL of ethanol, that is, 1 unit = 357 mL of 5% alcohol beer or 43 mL of 40% alcohol liquor or 147 mL of 12% alcohol wine) within 3 months before screening, or those who can't abstain from drinking during the experiment;
• Those who drink excessive tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 ml) every day within 3 months before screening;
• those who have participated in other drug clinical trials within 3 months before administration or who have not participated in clinical trials by themselves;
• Blood donation within 3 months before screening includes blood component or massive blood loss (≥450mL), and those who receive blood transfusion or use blood products are planned to donate blood during the test period;
• The subject (female) is in lactation;
• Those who can't tolerate venipuncture and have a history of fainting from needles and blood;
• Those who have special requirements for diet and cannot accept a unified diet;

Sponsors & Collaborators

• Overseas Pharmaceuticals, Ltd.: lead
• GX pharma technology (beijing) Co., Ltd: collaborator

Study Sites (1)

Tianjin Municipal People's Hospital

Tianjin, Tianjin Municipality, 300121, China

Location

MeSH Terms

Conditions

Seizures; Epilepsy

Interventions

brivaracetam; Tablets

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 18, 2022
• Study Start: September 13, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: February 1, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)