A Single Dose, Randomized, Open-label, One-period Parallel Bioequivalence Study of Generic Leflunomide 20 mg Film-coated Tablets and Reference Product (Arava®) in Healthy Thai Male Volunteers Under Fasting Conditions
概览
- 阶段
- 1 期
- 干预措施
- Leflunomide 20 mg Film-coated Tablet
- 疾病 / 适应症
- Healthy Volunteer
- 发起方
- International Bio service
- 入组人数
- 48
- 主要终点
- AUC0-72
- 状态
- 尚未招募
- 最后更新
- 2年前
概览
简要总结
This Study Aims to Assess the Relative Bioavailability, Including the Rate and Extent of Absorption, of 20 mg Leflunomide Tablets Compared to ARAVA® 20 mg Tablets. The Evaluation Will be Conducted Following a Single Oral Dose (1 x 20 mg Tablet) in Healthy Thai Male Volunteers Under Fasting Conditions.
详细描述
To compare the Bioavailability of leflunomide 20 mg tablets with that of ARAVA® 20mg tablets in healthy Thai Male Volunteers under fasting conditions
研究者
入排标准
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Leflunomide 20 mg Tablets (Test Drug)
Leflunomide 20 mg Tablets ,1 x 20 mg, single dose fasting.
干预措施: Leflunomide 20 mg Film-coated Tablet
ARAVA® 20 mg Tablets (Reference Drug)
ARAVA™ 20 mg Tablets,1 x 20 mg, single dose fasting.
干预措施: ARAVA® 20 mg Film-coated Tablet
结局指标
主要结局
AUC0-72
时间窗: Blood samples collected over 72 hour period
Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose
Cmax
时间窗: Blood samples collected over 72 hour period
Maximum Observed Concentration - Metabolite A77 1726 in Plasma