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CTRI Number  CTRI/2023/01/048928 [Registered on: 11/01/2023] Trial Registered Prospectively
Last Modified On: 04/05/2023
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Bioavailability study of Zolpidem Tartrate Sublingual Solution  
Scientific Title of Study   A randomized, open-label, two-treatment, two-period, two-sequence, single-dose, crossover, comparative bioavailability study of Zolpidem Sublingual Solution 3.85% (a dose of two sprays equivalent to 10 mg) of Troikaa Pharmaceuticals Ltd., India with Zolfresh® 10 mg (Zolpidem Tartrate tablets I.P. 10 mg) of Abbott India Limited, India in healthy, adult human subjects under fed conditions 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
22-VIN-0324 Version 01 dated 23 Aug 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Imran Ghanchi 
Designation  Principal Investigator 
Affiliation  Veeda Clinical Research Ltd. 
Address  Veeda Clinical Research Ltd 2nd 3rd and 4th Floor Shivalik Plaza A Near IIM Ambawadi

Ahmadabad
GUJARAT
380 051
India 
Phone  7967773000  
Fax    
Email  Imran.G2001@veedacr.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Vivek Kumar Agarwal  
Designation  Senior General Manager 
Affiliation  Troikaa Pharmaceuticals Ltd 
Address  Troikaa Pharmaceuticals Ltd Commerce House 1 Satya Marg Bodakdev Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  7926856242   
Fax    
Email  vivekagarwal@troikaapharma.com  
 
Details of Contact Person
Public Query  
Name  Mr Vivek Kumar Agarwal  
Designation  Senior General Manager 
Affiliation  Troikaa Pharmaceuticals Ltd 
Address  Troikaa Pharmaceuticals Ltd Commerce House 1 Satya Marg Bodakdev Ahmedabad


GUJARAT
380054
India 
Phone  7926856242   
Fax    
Email  vivekagarwal@troikaapharma.com  
 
Source of Monetary or Material Support  
Troikaa Pharmaceuticals Ltd. Commerce House-I Satya Marg Bodakdev Ahmedabad-380054 Gujarat India  
 
Primary Sponsor  
Name  Troikaa Pharmaceuticals Ltd  
Address  Troikaa Pharmaceuticals Ltd. Commerce House-I Satya Marg Bodakdev Ahmedabad-380054 Gujarat India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Imran Ghanchi  Veeda Clinical Research Ltd  Veeda Clinical Research Ltd 2nd 3rd and 4th Floor Shivalik Plaza A Near IIM Ambawadi
Ahmadabad
GUJARAT 		 7967773000

Imran.G2001@veedacr.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Anveshhan Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Zolfresh (Zolpidem Tartrate tablets) 10 mg of Abbott India Limited, India   Zolfresh 10 mg (Zolpidem Tartrate 10 mg tablets) Dosage: 1 tablet of 10 mg to be administtered orally with 240 ml water 
Intervention  Zolpidem Sublingual Spray 3.85% of Troikaa Pharmaceuticals Ltd., India  Zolpidem Sublingual Spray 3.85% Dosage: Two sprays equivalent to 10 mg Zolpidem Tartrate to be administered under the tongue 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Healthy human subjects aged between 18 and 45 years (both inclusive)
2. Subjects weight within clinically acceptable normal range according to normal values for Body Mass Index (18.50 to 30.00 kg/m2 (both inclusive)) with minimum of greater than equal to 45 kg weight
3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range
4. Non-smoker and non-alcoholics
5. Subjects having clinically acceptable 12-lead electrocardiogram (ECG)
6. Subjects having clinically acceptable chest X-Ray (PA view), if taken
7. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine)
8. Subjects having negative Urine Alcohol /alcohol breath test
9. Subjects willing to adhere to the protocol requirements and to provide written informed consent
10. For Male Subjects: Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study until 6 months after the last dose of the study medication as judged by the investigator(s), such as Condom with spermicide, Condom with diaphragm, or abstinence. Subjects should also not donate sperm and blood during this time
11. Subject having negative Urine Pregnancy test at screening and negative Serum Beta-hCG pregnancy test on admission day of Period 01 (only for female subjects).
12. For Female Subjects:
Female 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 intrauterine device (IUD), abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam.
Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

 
 
ExclusionCriteria 
Details  1. Hypersensitivity to Zolpidem or related class of drugs or any of its
excipients or heparin.
2. History or presence of significant cardiovascular, pulmonary, hepatic,
renal, gastrointestinal, endocrine, immunological, psychiatric, urogenital,
dermatological or neurological disease or disorder.
3. Any treatment which could bring about induction or inhibition of hepatic
microsomal enzyme system within 01 month prior to dosing in Period 01.
4. History or presence of alcoholism or drug abuse
5. History or presence of smoking.
6. History or presence of asthma, urticaria or other significant allergic
reactions.
7. History or presence of significant gastric and/or duodenal ulceration.
8. History or presence of significant thyroid disease, adrenal dysfunction,
organic intracranial lesion such as pituitary tumor.
9. History or presence of cancer or basal or squamous cell carcinoma.
10. Difficulty with donating blood.
11. Difficulty in swallowing solids like tablets or liquid spray like sublingual
solution.
12. Use of any prescribed medications and OTC medication Including
vaccines, herbal drugs and vitamins within 30 days prior to admission in
Period 01.
13. Major illness within past 03 months.
14. Volunteer who have donated blood (1 unit) or participation in a drug
research study within past 90 days prior to the first dose of the study
drug.
15. Consumption of grapefruit or grapefruit juice within 72.00 hours prior to
admission in period 01 and xanthine-containing products, tobacco
containing products or alcohol or alcohol containing products for within
48.00 hours prior to admission in period 01.
16. Volunteer who have been on an abnormal diet (for whatever reason)
during the four weeks preceding the study.
17. Positive screening test for any one or more: HIV, Hepatitis B and
Hepatitis C.
18. History or presence of significant easy bruising or bleeding.
19. History or presence of Impotence, Altered (decreased) libido, Ejaculation
disorders
20. History or presence of significant recent trauma.
21. Female Subjects who are lactating

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
PK Parameters: Cmax, AUC(0-t), AUC(0-∞), Tmax, AUC_% Extrap_obs, t1/2 and Kel.  The post-dose blood samples of 4.0 mL each will be drawn at 5
min, 10 min, 15 min, 20 min, 30 min, 45 min and 1.00, 1.33, 1.67,
2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00 12.00 and 16.00 hours after dosing in each study period. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of subjects.  Vital signs (blood pressure and radial pulse rate) will be measured before
dosing of investigational products (within one hour prior to dosing) and at
1.00, 3.00, 6.00, and 13.00 hours after dosing in each period.
Post-dose blood pressure and radial pulse rate will be measured within ±45
minutes of the scheduled time in sitting posture 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/01/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 

Zolpidem tartrate tablet is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration.

M/s Troikaa Pharmaceuticals Ltd. proposed to develop a new dosage form i.e. Sublingual Spray of Zolpidem

This is a randomized, open-label, two-treatment, two-period, two-sequence, single-dose, crossover, comparative bioavailability study of Zolpidem Sublingual Solution 3.85% (a dose of two sprays equivalent to 10 mg) of Troikaa Pharmaceuticals Ltd., India with

Zolfresh® 10 mg (Zolpidem Tartrate tablets I.P. 10 mg) of Abbott India Limited, India in healthy, adult human subjects under fed conditions.

 
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