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.

• Status: Active, not recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Overseas Pharmaceuticals, Ltd.
• Collaborator: GX pharma technology (beijing) Co., Ltd
• Treatments: Brivaracetam

Criteria

Inclusion Criteria:

1. 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;

2. Male and female subjects aged from 18 to 60 years (including 18 and 60 years);

3. 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);

4. 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;

5. 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;

6. 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;

7. Subjects can communicate well with researchers, and understand and abide by the requirements of this research.

Exclusion Criteria:

1. 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.;

2. Have a history of dysphagia or any gastrointestinal diseases that affect drug absorption;

3. 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;

4. 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.);

5. Screening those who have a history of drug abuse within 6 months before;

6. Screening those who have used drugs within the first 3 months;

7. Screening those who have been vaccinated within 2 months before screening;

8. 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;

9. 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;

10. 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;

11. those who have participated in other drug clinical trials within 3 months before administration or who have not participated in clinical trials by themselves;

12. 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;

13. The subject (female) is in lactation;

14. Those who can't tolerate venipuncture and have a history of fainting from needles and blood;

15. Those who have special requirements for diet and cannot accept a unified diet;

16. Screening those who have had significantly abnormal diet (such as dieting and low sodium) within 1 month before screening;

17. Subjects judged by other researchers to be unsuitable for participation