NCT00838630已完成1 期
A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Cilostazol, 100 mg, Compared to an Equivalent Dose of a Commercially Available Reference Drug Product in 36 Fasted, Healthy, Adult Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration
研究概览
简要总结
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test cilostazol formulation to an equivalent oral dose of the commercially available cilostazol in a test population of 36 adult subjects 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
- •Sex: Male and Female; similar proportion of each preferred. Female subjects must be surgically sterile for at least six (6) months or postmenopausal for at least one (1) year.
- •Age: At least 18 years.
- •Weight: Body Mass Index (BMI) of 30 or less.
- •Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory test, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:
- •Laboratory Tests:
- •Hemoglobin, hematocrit, RBC, WBC, differential count, serum electrolytes (Na, K, Cl), fasting blood glucose, BUN, bilirubin, creatinine, AST, ALT, LD, alkaline phosphatase, and urinalysis. HIV, Hepatitis B, Hepatitis C, and drugs of abuse testing will be done for screening purposes only. Urine drugs of abuse testing will be repeated at each check-in. Female subjects will have a serum pregnancy test done at screening and a urine pregnancy test prior to each study period at check-in.
- •Laboratory values which are greater than 20% of the normal range will not qualify unless specifically accepted (with comment) by the Principal Investigator. Results of HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study.
- •Electrocardiogram A 12-lead electrocardiogram (ECG) will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.
- •Subjects must read and sign the Consent Form.
排除标准
- •History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months.
- •History of sensitivity to cilostazol, quinolones, or any antiplatelet drug.
- •History of malignancy, stroke, diabetes, cardiac, renal or liver disease or other serious illness.
- •History of GERD (gastroesophageal reflux disease), malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
- •History of treatment for pulmonary obstruction or asthma within the past five (5) years.
- •History of severe headaches or migraines.
- •History of glaucoma.
- •History of chronic infectious disease.
- •History of psychiatric disorder.
- •History of thyroid disorder/disease.
- •History of hypertension.
- •Females who are capable of becoming pregnant or are lactating.
- •Inability to read and/or sign the consent form.
- •Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
- •Subjects who have donated blood within four (4) weeks prior to the initial dosing for this study.
- •Subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.). Three months abstinence is required.
研究组 & 干预措施
1
Experimental
干预措施: Cilostazol 100 mg tablets (Drug)
2
Active Comparator
干预措施: Pletal® 100 mg tablets (Drug)
结局指标
主要结局
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 96 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 96 hour period
Bioequivalence based on AUC0-inf
Cmax - Maximum Observed Concentration
时间窗: Blood samples collected over 96 hour period
Bioequivalence based on Cmax
次要结局
未报告次要终点
研究者
研究点 (1)
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