A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70 mg Alendronate/2800 IU Vitamin D3 Final Market Combination Tablet to a 70 mg Alendronate Marketed Tablet, and the Relative Bioavailability of Vitamin D3
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 244
- 主要终点
- Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet
研究概览
简要总结
This study will evaluate the bioequivalence of alendronate in combination with vitamin D (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or nonpregnant female age 18 to 65 years
- •Female of childbearing potential on appropriate method of contraception and not nursing
- •BMI (body mass index) less than or equal to 30 kg/m2
- •Subject is in good health
- •Willing to limit direct sunlight and apply sunscreen if in the sun more than 1 hour
排除标准
- •mental or legal incapacitation
- •received bisphosphonate treatment within 3 months of screening
- •unable to sit or stand upright for at least 2 hours
研究组 & 干预措施
Sequence 1
alendronate/vitamin D combination then alendronate
干预措施: alendronate sodium (+) cholecalciferol (Drug)
Sequence 2
alendronate then alendronate/vitamin D combination
干预措施: alendronate sodium (+) cholecalciferol (Drug)
Sequence 3
alendronate/vitamin D combination then vitamin D
干预措施: alendronate sodium (+) cholecalciferol (Drug)
Sequence 4
vitamin D then alendronate/vitamin D combination
干预措施: alendronate sodium (+) cholecalciferol (Drug)
结局指标
主要结局
Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet
时间窗: On Day 1 across the 36-hour urinary collection period (Periods 1 and 2).
Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose.
Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet
时间窗: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).
Serum vitamin D3 pharmacokinetic parameter AUC0-120 hr (area under the serum concentration-time curve) after treatment on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose.
Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet
时间窗: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).
Serum vitamin D3 pharmacokinetic parameter Cmax (maximum concentration observed in serum) after treatmen on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose.
次要结局
未报告次要终点