NCT00978055已完成1 期
Single-Dose Fasting Bioequivalence Study of Liothyronine Sodium Tablets (50 Mcg; Mylan) to Cytomel® Tablets (50 Mcg; King) in Healthy Euthyroid Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Bioequivalence
研究概览
简要总结
The objective of this study was to investigate the bioequivalence of Mylan's liothyronine sodium 50 mcg tablets to King's Cytomel® 50 mcg tablets following a single, oral 100 mcg (2 x 50 mcg) dose administration under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •healthy males and/or non-pregnant, non-lactating females, 18 years and older
- •able to swallow medication
排除标准
- •institutionalized subjects
- •history of any significant disease
- •use of any prescription or OTC medications within 14 days prior to start of study
- •received any investigational products within 30 days prior to start of study
研究组 & 干预措施
2
Active Comparator
Cytomel® Tablets, 50 mcg
干预措施: 2: Cytomel® Tablets (Drug)
1
Experimental
Liothyronine Sodium Tablets, 50 mcg
干预措施: 1: Liothyronine Sodium Tablets (Drug)
结局指标
主要结局
Bioequivalence
时间窗: within 30 days
次要结局
未报告次要终点
研究者
研究点 (1)
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