A Single-centre, interventional, prospective, single-arm study to evaluate the efficacy, safety, and bioavailability of Tizanidine Sublingual Tablets 1 mg in sleep disorder patients

Wishmen Lifesciences Pvt Ltd1 个研究点分布在 1 个国家目标入组 18 人开始时间: 2025年4月21日最近更新: 2025年10月3日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 18
试验地点: 1
主要终点: 5. Bioavailability

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Thisstudy is a single-center, interventional, prospective, single-arm study toevaluate the efficacy, safety, and bioavailability of Tizanidine SublingualTablets 1 mg in sleep disorder patients of investigator-initiated trial. Theprimary objective is to evaluate the sleep efficiency, sleep time andbioavailability of Tizanidine Sublingual Tablets 1 mg in sleep disorderpatients. The secondary objective is to monitor the safety and tolerability ofthe test product in non-smoking and non-alcoholic sleep disorder patients. Theprimary outcome measures are Sleep efficiency, NREM and REM sleep cycle forInsomnia condition and with Tizanidine treatment, Heart and breathing ratechanges, Pulse oxygen levels by Polysomnography on Day 0 and Day 14. Quality oflife shall be assessed by using Epworth sleeping scale (ESS), Sleep qualityshall be assessed by using Pittsburgh Sleep Quality Index (PSQI) on Day 0 andDay 14. Bioavailability shall also assessed by collecting samples on Day 1 andDay 2. Assessment of safety will be done by laboratory evaluations and vitalsand well-being questionnaire. The total number of subjects shall be 18. Thetreatment duration will be 14 days and the total duration of the study shall be16 days.

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Not Applicable

入排标准

年龄范围: 40.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•Age 40 to 60 years (Male and/or non-pregnant, non-lactating female).
•Non-smokers
•Non-alcoholics
•Patients with sleeping disturbance or disorder
•Patients with a BMI between 18.5 – 30.0 kg/m2 (inclusive of both).
•Healthy according to the laboratory results and physical examination, performed within Day -7 to Day
•Patients having normal 12-lead electrocardiogram (ECG).
•Patients having normal chest X- Ray (P/A view).
•A negative urine drug screening result for drug abuse.
•A negative urine alcohol test result.
•Patients able to communicate effectively.
•Patients willing to give written informed consent and adhere to all the requirements of this protocol.
•Ability to fast for at least 10.00 hours before dosing, 04.00 hours post dose and consume standard meals on visit
•If study Patient is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence: Or Is postmenopausal for at least 1 year.
•Or Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject).

排除标准

•Patients had a history of allergy to tizanidine or any inactive component.
•Patients with significant abnormalities in screening clinical laboratory parameters.
•Patients had orthopedic surgery within 6 weeks of screening.
•Patients had concurrent use of oral tizanidine or other anti-spasticity medications e.g. Baclofen, Neurontin.
•Patients had history or current use of any Diazepam derivates
•Patients had co-morbid conditions or other neurological disorders that would confound assessment of clinical parameters (e.g. epilepsy).
•Consumed caffeine and /or xanthine-containing foods or beverages (i.e., coffee, tea, and caffeine-containing sodas, colas, etc.), grape fruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and unwilling to follow throughout the study.
•Patients who are non-cooperative or parents/legal guardians were unwilling to sign consent form.
•History or presence of any medical condition or disease according to the opinion of the physician.
•History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
•Patients who are on strong CYP1A2 inhibitors (e.g., such as zileuton, other fluoroquinolones, antiarrythmics (amiodarone, mexiletine, propafenone and verapamil), cimetidine, famotidine oral contraceptives, acyclovir and ticlopidine).
•History of cholestatic jaundice/hepatic dysfunction.
•History of exacerbation of symptoms of myasthenia gravis.
•Difficulty with donating blood or difficulty in accessibility of veins.
•History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
•An unusual or abnormal diet within 48.00 hours prior to study check-in., for whatever reason e.g., because of fasting due to religious reasons.
•Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
•Pulse rate less than 60 beats/minute or more than 100 beats/minute.
•Respiratory rate less than 14 breathes per minute or more than18 breathes per minute.
•Use of any prescribed medication during last two weeks or 5 half-life of that particular drug whichever is higher before dosing and unwilling to follow throughout the study.
•Use of any OTC medication during last two weeks or 5 half-life of that particular drug whichever is higher before dosing and unwilling to follow throughout the study.
•Major illness during 90 days before screening.
•Participation in a drug research study within past 90 days.
•Donation of blood in the past 90 days prior to study check-in.