drugset / Trial / NCT06689436
Pivotal BE Study of TAH3311 ODF vs ELIQUIS® Tablet Under Fasted Condition in Healthy Volunteers
RandomizedCrossoverOpen-labelPrevention
Summary
This single-dose, open-label, randomized, four-way crossover study evaluates the pharmacokinetics, safety, and tolerability of TAH3311 5 mg in healthy volunteers under fasted and fed conditions.
Timeline
- Start
- 2024-11-16
- Primary completion
- 2025-01-15
- Completion
- 2025-04-01
Outcome
Met primary endpoint
release “泰合生技藥品公司宣布其TAH3311抗血栓口溶膜新藥美國Pivotal Study (樞紐試驗)初步試驗數據分析(preliminary report)結果成功達標。” tahopharma.com ↗
release “Cmax (最高血中濃度)與AUC(藥物動力學曲線下面積)之幾何平均數比值以及其90%信賴區間均達到生體相等性（Bioequivalence,BE）之法定標準80-125%範圍內” tahopharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | 5 mg | Oral |
Indications
No indication recorded.