NCT00846196已完成1 期
A Crossover Study to Assess the Bioequivalence of the Phase III and Commercial Risedronate 35 mg Delayed Release Formulations.
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
- 538
- 试验地点
- 2
- 主要终点
- Assess the bioequivalence (BE) between the commercial and the Phase III risedronate 35 mg DR formulations.
研究概览
简要总结
Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2), and exit procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female, 18 to 65 years of age
- •if female, non-lactating and either surgically sterile or postmenopausal
- •body mass index less than or equal to 32 kg/m2 at screening
排除标准
- •no use of a bisphosphonate within 1 month
- •no history of GI disease
- •no use of any medications within 7-14 days prior to scheduled dosing day
研究组 & 干预措施
2
Experimental
one commercial risedronate 35 mg DR tablet
干预措施: risedronate 35 mg DR (Commercial Tablet) (Drug)
1
Active Comparator
one Phase III risedronate 35 mg DR tablet
干预措施: risedronate DR (Phase III clinical supply) (Drug)
结局指标
主要结局
Assess the bioequivalence (BE) between the commercial and the Phase III risedronate 35 mg DR formulations.
时间窗: 72 hours post-dose
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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