A Randomized. Single-Dose, Two-Way Crossover Relative Bioavailability Study of Zonisamide Formulations in Normal, Healthy Men and Women Following a Standard Meal
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 on Cmax,AUC and Tmax Parameters
研究概览
简要总结
The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule dose in subjects fed a high standard fat meal.
详细描述
This was an open label, randomized, balanced, single dose, two-period, two-treatment, two-sequence crossover study, performed under fed conditions. Subjects were confined to the SFBC Clinical Research Facility from at least 10 hours prior to drug administration, until after the 24-hour post-dose blood draw, in each period. The treatment phases were separated by a washout period of 28 days.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is the individual a healthy, normal adult man or non-child bearing potential woman who volunteers to participate?
- •Is s/he at least 18 years of age?
- •Is his/her BMI between 19 and 30, inclusive?
- •Is s/he considered reliable and capable of understanding his/her responsibility and role in the study?
- •Has s/he provided written informed consent?
排除标准
- •Does the individual have a history of allergy or hypersensitivity to zonisamide or sulfonamides?
- •Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
- •Does s/he have serious psychological illness?
- •Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse?
- •Does s/he have a positive urine drug screen, or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test?
- •Has s/he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation?
- •Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken?
- •Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?
- •Is s/he unable to refrain from the use of all concomitant medications during the study?
- •Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
- •Has s/he donated plasma during the two week period preceding study initiation?
- •Has s/he received an investigational drug during the 30 day Period preceding study initiation?
研究组 & 干预措施
Zonisamide
Zonisamide Capsules 100 mg of Dr.Reddy's laboratories Limited
干预措施: Zonisamide (Drug)
Zonegran
Zonegran Capsules 100 mg of EISAI INC
干预措施: Zonegran (Drug)
结局指标
主要结局
Bioequivalence on Cmax,AUC and Tmax Parameters
时间窗: 3 months
次要结局
未报告次要终点