None listed
Conditions
Interventions
Intervention1: Tizanidine Sublingual Tablets 1 mg: one unit of Tizanidine Sublingual Tablet 1 mg will be dosed per day. The total duration of the treatment will be 14 days.
Control Intervention1: Not
Sponsors
Wishmen Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 40 to 60 years (Male and/or non-pregnant, non-lactating female). 2. Non-smokers 3. Non-alcoholics 4. Patients with sleeping disturbance or disorder 5. Patients with a BMI between 18.5 30.0 kg/m2 (inclusive of both). 6. Healthy according to the laboratory results and physical examination, performed within Day -7 to Day 0. 7. Patients having normal 12-lead electrocardiogram (ECG). 8. Patients having normal chest X- Ray (P/A view). 9. A negative urine drug screening result for drug abuse. 10. A negative urine alcohol test result. 11. Patients able to communicate effectively. 12. Patients willing to give written informed consent and adhere to all the requirements of this protocol. 13. Ability to fast for at least 10.00 hours before dosing, 04.00 hours post dose and consume standard meals on visit 1. 14. 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).
Exclusion criteria
Exclusion criteria: 1. Patients had a history of allergy to tizanidine or any inactive component. 2. Patients with significant abnormalities in screening clinical laboratory parameters. 3. Patients had orthopedic surgery within 6 weeks of screening. 4. Patients had concurrent use of oral tizanidine or other anti-spasticity medications e.g. Baclofen, Neurontin. 5. Patients had history or current use of any Diazepam derivates 6. Patients had co-morbid conditions or other neurological disorders that would confound assessment of clinical parameters (e.g. epilepsy). 7. 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. 8. Patients who are non-cooperative or parents/legal guardians were unwilling to sign consent form. 9. History or presence of any medical condition or disease according to the opinion of the physician. 10. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. 11. 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). 12. History of cholestatic jaundice/hepatic dysfunction. 13. History or presence of allergy or bronchial asthma. 14. History of exacerbation of symptoms of myasthenia gravis. 15. History or presence of significant alcoholism or drug abuse. 16. Difficulty with donating blood or difficulty in accessibility of veins. 17. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in. 18. 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. 19. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg. 20. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. 21. Pulse rate less than 60 beats/minute or more than 100 beats/minute. 22. Respiratory rate less than 14 breathes per minute or more than18 breathes per minute. 23. 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. 24. 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. 25. Major illness during 90 days before screening. 26. Participation in a drug research study within past 90 days. 27. Donation of blood in the past 90 days prior to study check-in. 28. Pregnancy or lactating Women(In case of Female participants).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sleep efficiency, NREM and REM sleep cycle for insomnia condition, heart and breathing rate and pulse oxygen levels by polysomnography. 2. Quality of life shall be assessed by using Epworth sleeping scale. 3. Sleep quality shall be assessed by using Pittsburgh Sleep Quality Index (PSQI). 4. Sleep diary 5. BioavailabilityTimepoint: At Baseline, Day 1 and Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of Tizanidine Sublingual Tablets 1 mgTimepoint: Baseline & at check-in, 0.00, 1.00, 3.00 & 7.00 hours on Day 1 & day 2, day 15. | — |
Countries
India
Contacts
Public ContactDr D Tejo Swaroop Kumar
Noah Therapeutics Private Limited
Outcome results
None listed