Safety and Pharmacokinetics of Orally Administered Strontium L-Lactate in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- iAUC-0.25-12h
研究概览
简要总结
No clinical trials have evaluated strontium L-lactate (SrLac), the strontium salt of the L-enantiomer of lactic acid. Therefore, this clinical study was conducted to obtain general safety and pharmacokinetic (PK) information following acute oral intakes of three doses of SrLac by healthy adults. The data provided valuable comparisons with the pharmacokinetics of other strontium salts that are in clinical use and allowed determination of the dose of SrLac that will be useful for the management of bone health.neficial for the treatment of low bone density of osteoporosis and osteopenia.
详细描述
Purpose: The aim of this clinical study was to obtain safety and pharmacokinetic information following acute oral intakes of three ascending doses of strontium L-lactate by healthy adults.
Subjects and methods: Ten healthy men and women, mean age 43 ± 2 years, ingested one of three ascending doses of strontium L-lactate (SrLac) once per week for three weeks in succession. Fasting blood collections were performed pre-dose and 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose for determination of serum strontium at each interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects' anonymity was maintained on electronic case report forms (eCRFs) and other documents by utilization of initials, number, or code, and not by using a subject's name. The Investigator kept a separate log showing codes, names, and addresses. All documents showing the subjects' identity were kept in strict confidence by the 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
- 未提供
排除标准
- •Subject has abnormal laboratory test results of clinical significance at Visit 1 (day -7) at the discretion of the Investigator. One re-test will be allowed on a separate day prior to Visit 2 (day 0), for subjects with abnormal laboratory test results.
- •Subject has a known allergy or sensitivity to any of the ingredients in the study products and/or any ingredients of the meals provided.
- •Subject has a history of anaphylaxis, a documented hypersensitivity reaction, and/or a clinically important reaction to any drug.
- •Subject has a history or presence of clinically important endocrine (including hyperparathyroidism, type l or 2 diabetes mellitus and/or hypoglycemia), cardiovascular (including, but not limited to history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic, dermatologic, neurologic (such as Alzheimer's or Parkinson's patients), rheumatic (including gout), biliary, and/or psychiatric disorders (including depression and/or anxiety disorders), that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
- •Subject has had a loss of 400 mL of blood (e.g., blood/plasma donation) during the prior 30 d of visit 2 (day 0).
- •Subject has a history or current GI disorder that, in the judgment of the Investigator, may have the potential to disrupt normal digestion and absorption.
- •Subject has a history or presence of cancer in the prior two years, except for non- melanoma skin cancer.
- •Subject has a history of bariatric surgery for weight reducing purposes.
- •Subject has recently (within 6 months prior to Visit 1; day -7) had a weight loss or gain >4.5 kg.
- •Subject has uncontrolled hypertension (systolic blood pressure 2:160 mm Hg or diastolic blood pressure 2:100 mm Hg) as defined by the blood pressure measured at Visit 1 (day -7). One re-test will be allowed on a separate day prior to Visit 2 (day 0), for subjects with abnormal blood pressure.
- •Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian, intentional consumption of a high fiber diet), in the opinion of the Clinical Investigator.
- •Subject is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
- •Subject has been exposed to any non-registered drug product within 30 d prior to visit I (day-7).
- •Subject has a recent history of (within 12 months of screening; Visit I; day -7) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink= 12 oz beer, 5 oz wine, or I Yi oz distilled spirits).
- •Individual has a condition the Clinical Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
研究组 & 干预措施
Strontium dose of 170 mg
The Sponsor provided each 170 mg dose of strontium as strontium L-lactate dry powder packaged in individual vials. The powder was prepared for consumption by adding 10 mL of distilled water to the vial and stirring until dissolution was complete. This liquid was then poured into an administration cup. An additional 10 mL of distilled water was used to rinse the remaining SrLac into the administration cup. Then 80 mL of distilled water was added directly into the administration cup. Following consumption of the 100 mL solution of SrLac, another 100 mL of distilled water was added into the administration cup, swirled, and consumed by the subject.
干预措施: Strontium L-lactate (Dietary Supplement)
strontium dose of 340 mg
The Sponsor provided each 340 mg dose of strontium as strontium L-lactate dry powder packaged in individual vials. The powder was prepared for consumption by adding 10 mL of distilled water to the vial and stirring until dissolution was complete. This liquid was then poured into an administration cup. An additional 10 mL of distilled water was used to rinse the remaining SrLac into the administration cup. Then 80 mL of distilled water was added directly into the administration cup. Following consumption of the 100 mL solution of SrLac, another 100 mL of distilled water was added into the administration cup, swirled, and consumed by the subject.
干预措施: Strontium L-lactate (Dietary Supplement)
Strontium dose of 680 mg
The Sponsor provided each 680 mg dose of strontium as strontium L-lactate dry powder packaged in individual vials. The powder was prepared for consumption by adding 10 mL of distilled water to the vial and stirring until dissolution was complete. This liquid was then poured into an administration cup. An additional 10 mL of distilled water was used to rinse the remaining SrLac into the administration cup. Then 80 mL of distilled water was added directly into the administration cup. Following consumption of the 100 mL solution of SrLac, another 100 mL of distilled water was added into the administration cup, swirled, and consumed by the subject.
干预措施: Strontium L-lactate (Dietary Supplement)
结局指标
主要结局
iAUC-0.25-12h
时间窗: 0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing
The primary outcome variable was the incremental area under the curve (iAUC) for serum strontium from pre-product consumption (t = -0.25 h) to 12 h (iAUC-0.25-12h).
次要结局
- (iAUC-0.25-∞)(0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing)
- Cmax(0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing)
- Tmax(0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing)
- K(0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing)
- t1/2(0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing)
- Oral bioavailability (F)(0.25 hour pre-dosing to 12 hours post-dosing on each day of dosing)