NCT01131949已完成1 期
Single Dose Two-Way Crossover, Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets With Lamictal 25 mg Chewable Tablets in Healthy Volunteers Under Fasting Condition
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Bioequivalence based on Cmax and AUC parameters
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics and bioequivalence of lamotrigine formulations after administration of single doses to non-smoking, healthy volunteers under fasted conditions.
详细描述
A single-dose, two-way, bioequivalence study in up to 26 normal, non-smoking, healthy males and females will be utilized to evaluate the pharmacokinetics and bioequivalence of Lamotrigine chewable dispersible formulations under fasted conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 41 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. (Appendix I and II).
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 (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism.
- •Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or 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-therapeutic indications as judged by the attending physician.
- •Tobacco use (>5 cigarettes per day) in the 3 months prior to study dosing.
- •If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of 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 (chewable, dispersible)
Experimental
Lamotrigine Tablets (chewable, dispersible),25 mg of Dr. Reddy's Laboratories Limited
干预措施: Lamotrigine (Drug)
Lamictal
Active Comparator
Lamictal Tablets 25 mg of Glaxo SmithKline
干预措施: Lamotrigine (Drug)
结局指标
主要结局
Bioequivalence based on Cmax and AUC parameters
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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