Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Fluconazole Tablets 200 mg and PFIZER (DIFLUCAN) 200 MG in Healthy Males Under Fed Condition.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC)
研究概览
简要总结
The objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®) 200 mg fluconazole tablets under fed conditions.
详细描述
Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 16 healthy adult male volunteers. A total 15 subjects completed the clinical phase of the study. In each period, subjects were housed from the mornings dosing until after the 72-hour blood draw. Single oral 200 mg doses were separated by a washout period of 21 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History or presence of significant:
- •cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- •In addition, history or presence of:
- •alcoholism or drug abuse within the past year;
- •hypersensitivity or idiosyncratic reaction to fluconazole or other azoles. Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days prior to first dose.
- •Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days prior to first dose.
- •Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dosing.
- •Subjects who, through completion of the study, would have donated in excess of:
- •500 mL of blood in 14 days, or
- •500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
- •1000 mL of blood in 90 days,
- •1250 mL of blood in 120 days,
- •1500 mL of blood in 180 days,
- •2000 mL of blood in 270 days,
- •2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.
研究组 & 干预措施
Diflucan
Diflucan 200 mg fluconazole tablets of Pfizer
干预措施: Fluconazole (Drug)
Fluconazole
Fluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited.
干预措施: Fluconazole (Drug)
结局指标
主要结局
Area Under Curve (AUC)
时间窗: pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 9, 12, 24, 48 and 72 hours post-dose.
次要结局
未报告次要终点