Single Dose, Two-way, Crossover, Oral Bioequivalence Study of Lamotrigine Tablets 200 mg With Lamictal® Tablets 200 mg in Healthy, Volunteers Under Fasting Condition.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area under curve (AUC)
研究概览
简要总结
This is an single dose,two-way, crossover, oral bioequivalence study.
详细描述
The study was an single dose, two-way crossover, oral bioequivalence study of Lamotrigine tablets 200 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL® tablets 200 mg of GlaxoSmithKline Inc, in healthy, adult, human subjects under fasting condition. 26 subjects (19 men and 7 womens) are enrolled and completed the study. The washout period is 14 days between the two periods of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females at least 18 years of age inclusive
- •Informed of the nature of the study and given written informed consent
- •Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs.
排除标准
- •Hypersensitivity to Lamotrigine (Lamictal®) or similar compounds
- •Any history of a clinical condition which might affect drug absorption, metabolism or excretion
- •Recent history of mental illness, drug addition,drug abuse or alcoholism
- •Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing of difficulty in donating blood.
- •Received an investigational drug within the 4 weeks prior to study dosing.
- •Currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the -counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutics indications as judged by the attending physician.
- •Tobacco use (>5 cigarettes per day) in the 3 months prior to study dosing.
- •If female, the subjects is lactating or has a positive pregnancy test screening and prior to each of the two treatments periods. Females of child bearing potential must use a medical acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods or contraception that may be used by the subject and/or her partner are; oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
研究组 & 干预措施
Lamotrigine Tablets 200 mg
Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited
干预措施: Lamotrigine (Drug)
Lamotrigine Tablets 200 mg
Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited
干预措施: Lamictal® (Drug)
Lamictal® 200 mg Tablets
Lamictal® 200 mg Tablets of GlaxoSmithKline Inc
干预措施: Lamotrigine (Drug)
Lamictal® 200 mg Tablets
Lamictal® 200 mg Tablets of GlaxoSmithKline Inc
干预措施: Lamictal® (Drug)
结局指标
主要结局
Area under curve (AUC)
时间窗: Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,36,48,72,96,120 hours
次要结局
未报告次要终点