NL-OMON25974招募中不适用
Evaluating the effect of zolpidem and suvorexant in healthy elderly volunteers on walking (adapt)ability.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHDR
- 入组人数
- 18
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and female subjects aged between 65 years and 80 years (inclusive) at screening.
- •2. Body mass index (BMI) within the range of 18 to 30 kg/m2 (inclusive) at screening.
- •3. Systolic blood pressure 100-160 mmHg, diastolic blood pressure 50-95 mmHg, and pulse rate 45-100 bpm(inclusive), measured on either arm, after 5 min in the supine position at screening.
- •4. Estimated creatinine clearance (using the Cockcroft &Gault formula) =60 mL/min to allow for some reduced renal function in the elderly.
- •5. Subject has a regular sleep pattern (bedtime between 22:00 and 00:30 and sleep for at least 6 h).
排除标准
- •1. Hypersensitivity to benzodiazepines and/ or meeting contraindication criteria for zolpidem: myasthenia gravis, sleep apnea syndrome, liver failure, respiratory depression.
- •2. Hypersensitivity to orexin antagonist and/ or meeting contraindication criteria for suvorexant: narcolepsy.
- •3. Regular use of sedative/hypnotic drugs.
- •4. Regular use of walking aids.
- •5. Recurrent fallers defined as > 3 falls per year.
- •6. Neurological diseases and/or orthopedic problems interfering with gait function
- •7. Mini Mental State Examination score < 25 at Screening.
- •8. Current or previous diagnosis of insomnia-related disorder according to the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria.
- •9. Vaccination for SARS-CoV-2 within 4 days of screening and/or dosing with study drug.
研究者
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