| CTRI Number |
CTRI/2025/04/084452 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate the Efficacy, safety, and bioavailability of Tizanidine Sublingual Tablets 1 mg in sleep disorder patients. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 001-25, Version No.: 01, dated 06 Mar 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D Tejo Swaroop Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Noah Therapeutics Private Limited |
| Address |
Noah Therapeutics Private Limited
D.No.7-1-645/A, Sanathnagar, Erragadda,
Hyderabad
TELANGANA
500018
India |
| Phone |
09958509329 |
| Fax |
|
| Email |
tejoswaroopd@noahtherapeutics.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Tejo Swaroop Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Noah Therapeutics Private Limited |
| Address |
Noah Therapeutics Private Limited
D.No.7-1-645/A, Sanathnagar, Erragadda,
Hyderabad
TELANGANA
500018
India |
| Phone |
09958509329 |
| Fax |
|
| Email |
tejoswaroopd@noahtherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Tejo Swaroop Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Noah Therapeutics Private Limited |
| Address |
Noah Therapeutics Private Limited
D.No.7-1-645/A, Sanathnagar, Erragadda,
Hyderabad
TELANGANA
500018
India |
| Phone |
09958509329 |
| Fax |
|
| Email |
tejoswaroopd@noahtherapeutics.com |
|
|
Source of Monetary or Material Support
|
| Wishmen Lifesciences Pvt. Ltd., P. No. 4 & 4/a, 8-2-293, Road No.-14, Banjara Hills, Hyderabad, Khairtabad, Telangana, India, 500034
Email: drpavan@wishmen.life |
|
|
Primary Sponsor
|
| Name |
Wishmen Lifesciences Pvt Ltd |
| Address |
P. No. 4 & 4/a, 8-2-293, Road No.-14, Banjara Hills, Hyderabad, Khairtabad, Telangana, India, 500034
Email: drpavan@wishmen.life |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D Tejo Swaroop Kumar |
Noah Therapeutics Private Limited |
D.No.7-1-645/A, Sanathnagar, Erragadda, Hyderabad, Telangana -500018 (India)
Phone No.: +91 9958509329
Hyderabad
TELANGANA |
09958509329
tejoswaroopd@noahtherapeutics.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, St. Theresa’s Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sleep disorder patients otherwise healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
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. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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).
|
|
| ExclusionCriteria |
| Details |
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). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. Bioavailability |
At Baseline, Day 1 and Day 14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of Tizanidine Sublingual Tablets 1 mg |
Baseline & at check-in, 0.00, 1.00, 3.00 & 7.00 hours on Day 1 & day 2, day 15. |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="16" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
study is a single-center, interventional, prospective, single-arm study to
evaluate the efficacy, safety, and bioavailability of Tizanidine Sublingual
Tablets 1 mg in sleep disorder patients of investigator-initiated trial. The
primary objective is to evaluate the sleep efficiency, sleep time and
bioavailability of Tizanidine Sublingual Tablets 1 mg in sleep disorder
patients. The secondary objective is to monitor the safety and tolerability of
the test product in non-smoking and non-alcoholic sleep disorder patients. The
primary outcome measures are Sleep efficiency, NREM and REM sleep cycle for
Insomnia condition and with Tizanidine treatment, Heart and breathing rate
changes, Pulse oxygen levels by Polysomnography on Day 0 and Day 14. Quality of
life shall be assessed by using Epworth sleeping scale (ESS), Sleep quality
shall be assessed by using Pittsburgh Sleep Quality Index (PSQI) on Day 0 and
Day 14. Bioavailability shall also assessed by collecting samples on Day 1 and
Day 2. Assessment of safety will be done by laboratory evaluations and vitals
and well-being questionnaire. The total number of subjects shall be 18. The
treatment duration will be 14 days and the total duration of the study shall be
16 days. |