Randomized, 2-Way Crossover, Bioequivalence Study of Topiramate 25 mg Capsules and Topamax® 25 mg Capsules Administered as the Content of 2 x 25 mg Capsules Mixed With Applesauce in Healthy Subjects Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 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 was to compare the rate and extent of absorption or topiramate 25 mg capsules (test) versus Topamax® (reference) administered as the content of 2 x 25 mg capsules mixed with applesauce 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 or older
- •Subjects should read, sign and date an Informed Consent Form prior to any study procedures.
- •Female subjects will be post-menopausal or surgically sterilized.
- •Post menopausal status is defined as absence of menses for the past 12 months or bilateral oophorectomy at least 6 months ago or hysterectomy with bilateral oophorectomy at least 6 months ago.
- •Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation aat least 6 months ago.
排除标准
- •Clinically significant illnesses within 4 weeks of the administration of study medication.
- •Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- •Any history or presence of significant neurological, hepatic, renal, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
- •Any clinically significant abnormality found during medical screening.
- •Abnormal laboratory tests judged clinically significant.
- •Positive urine drug screen at screening.
- •Positive alcohol breath test at screening.
- •Subjects who use tobacco in any form will not be eligible to participate in this study. Three months abstinence is required.
- •Positive testing for hepatitis B, hepatitis C or HIV at screening.
- •ECG or vital sign abnormalities (clinically significant).
- •Subjects with BMI greater than or equal to 30.
- •History of significant alcohol abuse within 6 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 (PCP) and crack) within 1 year of the screening visit.
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subjects participation in this study.
- •History of allergic reactions to topiramate.
- •Use of any drugs known to induce or inhibit hepatic drug metabolism, 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 within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- •Donation of plasma (500 mL) within 7 days or donation or significant loss of whole blood (500 mL) within 56 days prior to administration of the study medication.
- •Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
- •Additional exclusion criteria for females only:
- •Positive urine pregnancy test at screening (performed on all females).
研究组 & 干预措施
Test First
Topiramate Capsules 25 mg
干预措施: Topiramate 25 mg Capsules (Drug)
Test First
Topiramate Capsules 25 mg
干预措施: Applesauce (Other)
Reference First
Topamax® 25 mg Capsule
干预措施: Topamax® 25 mg Capsules (Drug)
Reference First
Topamax® 25 mg Capsule
干预措施: Applesauce (Other)
结局指标
主要结局
Cmax - Maximum Observed Concentration
时间窗: Blood samples collected over 168 hour period
Bioequivalence based on Cmax
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration
时间窗: Blood samples collected over 168 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 168 hour period
Bioequivalence based on AUC0-inf
次要结局
未报告次要终点