A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)
研究概览
简要总结
This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal female, in good health (at least 5 years since last menses)
- •Age ≥45 and ≤70
- •Weight + or - 20% of the Metropolitan Life weight table
- •Plasma C-terminal telopeptide of type I collagen (CTx-1) ≥ 0.25 ng/mL
- •Total calcium (Ca++), phosphorus (P), and magnesium (Mg++) within normal range
- •Willing and able to comply with all study requirements
- •Willing and able to sign written informed consent
- •Negative urine pregnancy test at screening
- •Negative Screen for Hepatitis B and C, human immunodeficiency virus (HIV) and drugs of abuse
排除标准
- •History of parathyroid, thyroid, pituitary or adrenal diseases
- •History of musculoskeletal disease
- •History of gastro-esophageal reflux disease (GERD) or other significant gastrointestinal disorders
- •History of cancer within 5 years of enrollment other than basal cell carcinoma
- •History of regular use of non-steroidal anti-inflammatory drugs (NSAID)
- •History of surgery within 60 days of enrollment
- •History of hypersensitivity or allergies (other than seasonal allergies) within 5 years of enrollment including known sensitivity to the active ingredients or the excipients in the study medications
- •Use of concomitant medications other than acetaminophen within 7 days of enrollment or anticipated need to use such concomitant medications during the study
- •Use of bisphosphonates within 6 months, selective selective estrogen receptor modulators (SERMS), estrogen or estrogen-like drugs 2 months, or calcitonin 1 month
- •Presence of any clinically significant illness
- •Unwilling or unable to comply with all study requirements
- •Unwilling or unable to sign written, informed consent
- •History of drug or alcohol abuse
- •Participation in any clinical study of an investigational drug within 60 days of enrollment
- •Plasma CTx-1 less than 0.25 ng/mL
研究组 & 干预措施
rsCTA
Oral Tablet
干预措施: Oral Tablet (Drug)
rsCTB
Oral Tablet
干预措施: Oral Tablet (Drug)
Fortical
Nasal Spray
干预措施: Recombinant Salmon Calcitonin (rsCT) (Drug)
Fortical
Nasal Spray
干预措施: Nasal Spray (Drug)
结局指标
主要结局
Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)
时间窗: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours (Fortical): 0, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 10, 12, 24 hours rsCTA and rsCTB
This study compared the exposure to recombinant salmon calcitonin (rsCT), as measured by a decrease in plasma C-terminal telopeptide of type I collagen (CTx-1), of single doses of rsCT tablets containing 150 µg and 200 µg rsCT, respectively, with Fortical® nasal spray.
次要结局
未报告次要终点