NCT01526278已完成1 期
Pharmacokinetics of a Single Oral Dose of Maxmarvil® in Healthy Postmenopausal Women Without a Previous History of Fractures
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
- 18
- 试验地点
- 1
- 主要终点
- analysis of Alendronate concentrate
研究概览
简要总结
This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women
详细描述
Pharmacokinetics of a single Oral Dose of Maxmarvil® in healthy postmenopausal women without a previous history of fractures
- evaluation of Pharmacokinetics
- Urine collection : Pre-dose(pre 1hour), post-dose 0~6 hour, 6~12 hour, 12~24 hour
- Evaluation Variables : Aet
- Evaluation of safety, pharmacodynamics
- Adverse Event : check it every and frequently
- Physical exam : screening, just before injection, post-dose 24 hour and post-study visit
- Vital sign : screening, just before injection, post-dose 1 hour, 24 hour and post-study visit
- Laboratory test : screening, post-dose 24hour
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Screening test in healthy postmenopausal women without a previous history of fracture
- •Normal range in laboratory test arranged by principal investigator because of the character of medicine
- •over 50kg, body weight is in ± 20% of ideal body weight Written concent by himself and following the protocol after understanding of the explained clinical trial
排除标准
- •Subject who have taken something to induce and inhibit the drug metabolizing enzyme within 1 month like Barbiturate.
- •Subject who have a history of drug abuse and got a positive in urine test for drug abuse.
- •Subject who have taken a prescription only medicine or an oriental medicine within 2 weeks after first administration the clinical drug trial , taken a OTC within 1 week after first administration the clinical drug trial like some OTC including calcium, an antacids, multiple vitamin, mineral.
- •Subject who have been chronic drinking(over 21 units/week) or can not stop drinking during the clinical trial.
- •Subject who have smoked over 10 unit/day for 3months.
- •Subject who have light or clear hypersensitivity reaction about OTC(aspirin, antibiotic medication) or bisphosphonates(alendronate)
- •Subject who have got a disease about liver, kidney, neurology, respiratory, endocrine, hematooncology, cardiovascular, musculoskeletal, psychological or history of fracture within 12months or a tooth extraction within 6month
- •Subject who have a history of gastrointestinal disease or stomach surgery without appendectomy, herniotomy having an effort the absorb of clinical drug trial.
- •Subject who have a esophageal disease like esophagitis, esophageal ulcer, esophagus erosion, esophagorrhaphy, esophagostenosis, dysphagia.
- •Subject who can not keep the sitting position for 30minutes
- •Subject who is out of normal range of calcium concentration in blood (8.8 ~ 10.5 mg/dl)
- •Subject who is hypotension(systolic blood pressure ≤ 90mmHg or diastolic blood pressure ≤ 50 mmHg ) or hypertension(systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100 mmHg ) in sitting position after rest 3 minutes
- •join the other clinical trial within 2months after administration of the clinical drug trial.
- •Subject who have donated whole blood within 2 months or plasma within 1 month.
- •Subject who have a grapefruit and something including caffeine in close season(from 3 days before administration to discharge from the hospital )
- •For the result of laboratory and the other reason subject is considered unsuitable by principal's decision
研究组 & 干预措施
Maxmarvil®
Other
single-arm study
干预措施: Maxmarvil® (Drug)
结局指标
主要结局
analysis of Alendronate concentrate
时间窗: pre-dose, post dose 0-6hour, 6-12hour, 12-24hour
If the CrCL value is less than 75%, it is considered that collected urine is not appropriate and collected urine is exclusived for analysis of pharmacokinetics
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)Cytomegalovirus (CMV)NCT05319353Takeda80
已完成
1 期
Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy AdultsInsomniaNCT00914862Takeda56
已完成
1 期
Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress SyndromeSepsisAcute Respiratory Distress SyndromeAcute Lung InjuryNCT01438853Altor BioScience18
已完成
1 期
A Pharmacokinetic and Safety Study of Single and Multiple Doses of Rabreprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Years Old, InclusiveGERDNCT00747695Johnson & Johnson Pharmaceutical Research & Development, L.L.C.31
已完成
1 期
Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With EpilepsyEpilepsyNCT01284530Supernus Pharmaceuticals, Inc.30