KCT0004153招募中未知
A randomized, open-label, single dose, 2-sequence, 2-period crossover study to explore the safety and pharmacokinetic characteristics of Teribone injection 56.5ug and Rap18001 in postmenopausal female volunteers
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 50(Year) 至 o Limit（—）
- 性别
- Female
入选标准
- •1. Healthy woman and age 50 years or more and naural monopause for 1year or more or surgical menopause at the time of screening
- •2. Body mass index(BMI) more than 17.5kg / m2 and less than 30.5kg / m2 and weight more than 45kg
- •3. Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as electrocardiography(ECG) test.
- •4. Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital Institutional Review Board(IRB).
- •5. Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.
排除标准
- •1. Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
- •2. Those who show the following figures as a result of laboratory tests
- •? ALT or AST> 2 times upper limit of normal range
- •? ALP> 2 times upper limit of normal range
- •? Total calcium> 1.5 times upper limit of normal range
- •3. Patients with Pager's disease
- •4. Patients who had been undergone radiation therapy for bones
- •5. Patients with primary malignant bone tumors or metastatic bone tumor
- •6. Patients with metabolic bone disease except Osteoporosis (hyperparathyroidism etc.)
- •7. Patients with a history of hypersensitivity to the test drug or the components of the test drug
- •8. When the left-sided blood pressure is more than 150 mmHg or less thean 100mmHg (systolic blood pressure) or more than 100 mmHg or less then 60 mmHg (diastolic blood pressure)
- •9. Patients with severe renal impairment (eGFR<30 ml/min/1.73m2)
- •10. Patients with severe heart disease
- •11. Patients with severe hepatic impairment
- •12. Patients with urinary stone
- •13. History of significant alcohol abuse or drug abuse within one year prior to the Screening
- •14. Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing
- •15. Subjects who treated with digitalis or activated vitamin D (alfacalcidol, calcitriol, eldecalcitol, maxacalcitol, falecalcitriol)within 10days prior to the first dosing
- •16. Alcohol > 210g/week, within 6 months prior to the screening
- •17. Smoker (= 20cigarettes/day), within 6 months prior to the screening
- •18. Subject who done the whole blood donation within two months or component blood donation within 1 month prior to the first dosing
- •19. Subject who has participated in any other clinical trials or bioequivalence study and has had medication within 6 months prior to the day of the first administration of investigational product
- •20. Subjects who is determined by investigator's decision as unsuitable for clinical trial participation
研究者
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