NL-OMON50820已完成不适用
Evaluating the effect of zolpidem and suvorexant in healthy elderly volunteers on walking (adapt)ability. - Evaluating the effect of zolpidem and suvorexant on walking ability.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male and female subjects aged between 65 years and 80 years (inclusive) at
- •2. Body mass index (BMI) within the range of 18 to 30 kg/m2 (inclusive) at
- •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
- •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)
- •9. Vaccination for SARS-CoV-2 within 4 days of screening and/or dosing with
- •study drug.
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