A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70-mg Alendronate/5600 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
- 318
- 主要终点
- Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D
研究概览
简要总结
This study will evaluate the bioequivalence of alendronate in combination with vitamin D compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.
This was an open-label, randomized, 2-part, crossover study. Each participant participated in one part of the study only (i.e., each participant participated only in Part I or only in Part II). Participants entered the study sequentially within each part of the study. A washout of at least 12 days separated each treatment period within each part of the study.
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 85 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 85 years
- •female of childbearing potential on appropriate method of contraception and not nursing
- •Body Mass Index (BMI) less than or equal to 30 kg/m2
- •subject is in good health
排除标准
- •mental or legal incapacitation
- •received bisphosphonate treatment within 3 months of enrollment.
- •unable to sit or stand upright for at least 2 hours
- •unwilling to refrain from consumption of alcohol or caffeinated products from 24 hours prior and 36 hours after study drug administration
- •unwilling to limit alcohol consumption to no more than 2 drinks per day
- •unwilling to limit caffeinated products to the equivalent of 4 cups of coffee per day or equivalent.
- •unwilling to refrain from smoking during the study
研究组 & 干预措施
Sequence 3 alendronate+vitamin D combination then vitamin D
Participants in Part 2 received 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period.
干预措施: alendronate sodium+vitamin D combination (Drug)
Sequence 1- alendronate+vitamin D combination then alendronate
Participants in Part 1 received 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period.
干预措施: alendronate sodium+vitamin D combination (Drug)
Sequence 2 alendronate then alendronate+vitamin D combination
Participants in Part 1 received 70mg alendronate tablet in Period 1 followed by 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
干预措施: alendronate sodium+vitamin D combination (Drug)
Sequence 4- vitamin D then alendronate+vitamin D combination
Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
干预措施: alendronate sodium+vitamin D combination (Drug)
结局指标
主要结局
Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D
时间窗: Day 1 across the 80-hour plasma collection period (Period 1 and 2)
The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.
Part 1: Urinary Excretion of Alendronate
时间窗: Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)
Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. 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 on Days 1 and 2.
次要结局
- Part II : Maximum Concentration (Cmax) of Vitamin D(Day 1 across the 80-hour plasma collection period (Periods 1 and 2))