NCT00605371已完成1 期
A Pivotal, Single-Dose, Randomised, Parallel-Group, Open-Label Study to Demonstrate Bioequivalence of 250mg Lamotrigine XR Relative to 200mg + 50mg Lamotrigine XR and to Demonstrate Lack of Food Effect on 250mg Lamotrigine XR in Healthy Male and Female Volunteers
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
- 209
- 试验地点
- 1
- 主要终点
- Pharmacokinetics ie Serum lamotrigine Cmax and AUC(0-inf)
研究概览
简要总结
This study intends to demonstrate bioequivalence and lack of food effect on 250mg lamotrigine XR in healthy male and female volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged from 19 to 55 years, inclusive.
- •Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 - 32 kg/m2 inclusive.
- •Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, vital signs and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures
- •Female subjects of non-child bearing potential will be eligible to participate if they meet the following criteria:
- •Post-menopausal females defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However if indicated this should be confirmed by oestradiol and FSH levels consistent with menopause (according to local laboratory ranges).
- •Pre-menopausal females with a documented (medical report verification) hysterectomy and/or bilateral oophorectomy, the latter only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- •Female subjects of child bearing potential will be eligible to participate if they comply with the contraception requirements.
- •A negative pre-study Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, and HIV antibody result at screening.
- •A negative pre-study urine drug screen.
- •A negative screen for alcohol (urine, blood or breath test).
- •Signed and dated written informed consent prior to admission to the study.
排除标准
- •Female subjects of childbearing potential will not be eligible to participate who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria from at least the commencement of their last normal period prior to the first dose of study medication; and to continue until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after treatment or 5 half lives of the study medication, whichever is the longest .
- •Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at screening) or lactating.
- •Female subjects using hormonal contraceptive precautions including progesterone-coated IUD.
- •Female subjects using oestrogen-containing hormone replacement therapy.
- •Subjects who have received lamotrigine previously (subjects who received placebo in a previous study will be allowed)
- •History or evidence of drug or alcohol abuse within 12 months of study start.
- •QTc >450msec for women and QTc >430 msec for men on the screening 12-lead ECG.
- •Current smokers of 10 or more cigarettes per day.
- •History of regular alcohol consumption averaging >7 drinks/week for women or >14 drinks/week for men within 6 months of screening. One drink is equivalent to 12 g alcohol = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
- •Has received prescribed or non-prescribed medication (including vitamins and herbal remedies) within 14 days prior to the dosing day, which in the opinion of the Principal/Co-Investigator, may interfere with the study procedures or compromise safety.
- •History of gastro-intestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •History of clinically relevant skin rashes that, in the opinion of the investigator, might interfere with the conduct of the study.
- •Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
- •History of allergic, anaphylactic, hypersensitivity or idiosyncratic reaction(s) to lamotrigine or drugs of a similar type.
研究组 & 干预措施
Subjects receiving regimen A
Experimental
Eligible subjects will receive regimen A containing lamotrigine extended release tablet of 200 milligrams plus 50 milligrams in fasted state
干预措施: Lamotrigine tablet (Drug)
Subjects receiving regimen B
Experimental
Eligible subjects will receive regimen B containing lamotrigine extended release caplet of 250 milligrams in fasted state.
干预措施: Lamotrigine caplet (Drug)
Subjects receiving regimen C
Experimental
Eligible subjects will receive regimen C containing lamotrigine extended release caplet of 250 milligrams in fed state.
干预措施: Lamotrigine caplet (Drug)
结局指标
主要结局
Pharmacokinetics ie Serum lamotrigine Cmax and AUC(0-inf)
时间窗: Pre-dose and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26, 36, 48, 72, 96, 120 and 144 hours Post-dose
次要结局
- Serum lamotrigine AUC (0-t), tmax and t1/2(Pre-dose and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26, 36, 48, 72, 96, 120 and 144 hours Post-dose)
- PK (AUC (0-t), tmax and t1/2 )(Pre-dose and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26, 36, 48, 72, 96, 120 and 144 hours Post-dose)
- Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate(Up to day 21)
研究者
研究点 (1)
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