Randomized, 2-Way Crossover, Bioequivalence Study of Lamotrigine 25 mg Chewable Dispersible Tablets and Lamictal® 25 mg Chewable Dispersible Tablets in Healthy Subjects Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Concentration
研究概览
简要总结
The objective of this study is to compare the rate and extent of absorption of lamotrigine 25 mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg chewable dispersible tablets under fasting conditions.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be females and/or males, non-smokers, 18 years of age and older.
- •Female subjects will be post-menopausal or surgically sterilized.
- •Post-menopausal status is defined as absence of menses for the past 12 months or hysterectomy with bilateral oophorectomy at least 6 months ago.
- •Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.
排除标准
- •Clinically significant illnesses within 4 weeks of the administration of the study medication.
- •Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- •Any clinically significant abnormality found during medical screening.
- •Subjects with a history of renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
- •Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
- •Abnormal laboratory tests judged clinically significant.
- •Positive urine drug screen at screening.
- •Positive testing for hepatitis B, hepatitis C or HIV at screening.
- •ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90; or heart rate less than 50 bpm) at screening.
- •Subjects with BMI ≥ 30.
- •History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit - 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
- •History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PVP) and crack) within 1 year of the screening visit.
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
- •History of allergic reactions to lamotrigine.
- •Use of any drugs known to induce or inhibit drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine, valproic acid), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- •Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural products, vitamins, garlic as supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- •Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.
- •Subjects who have dentures or braces.
- •Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follow: less than 300 mL of whole blood within 30 days; 300 mL to 500 mL of whole blood within 45 days; more than 500 mL of whole blood within 56 days.
- •Positive alcohol breath test at screening.
- •Subjects who have used tobacco in any form within 90 days preceding study drug administration.
- •Female subjects: breast-feeding subjects.
- •Female subjects: positive urine pregnancy test at screening.
研究组 & 干预措施
Lamotrigine
Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
干预措施: Lamotrigine 25 mg Chewable Tablets (Drug)
Lamictal®
Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
干预措施: Lamictal® 25 mg Chewable Tablets (Drug)
结局指标
主要结局
Cmax - Maximum Observed Concentration
时间窗: Blood samples collected over 120 hour period
Bioequivalence basd on Cmax
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
时间窗: Blood samples collected over 120 hour period
Bioequivalence based on AUC0-t
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
时间窗: Blood samples collected over 120 hour period
Bioequivalence based on AUC0-inf
次要结局
未报告次要终点