| CTRI Number |
CTRI/2022/03/040997 [Registered on: 10/03/2022] Trial Registered Prospectively |
| Last Modified On: |
01/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover 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 Tartrate Sublingual Solution
3.85% (a dose of two sprays equivalent to 10 mg) of Troikaa Pharmaceuticals Ltd.,
India with Zolfresh (Zolpidem Tartrate tablets) 10 mg of Abbott India Limited, India in
healthy, adult subjects under fasting conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21-VIN-0158, Version 01, 04 Aug 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Darshan Kharadi |
| Designation |
Principal Investigator |
| Affiliation |
Veeda Clinical Research Ltd |
| Address |
Veeda Clinical Research Pvt. Ltd. Shivalik Plaza Near I.I.M. Ambawadi Ahmedabad – 380015 Gujarat India
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-67773000 |
| Fax |
079-67773000 |
| Email |
darshan.kharadi@veedacr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Vivek Kumar Agarwal |
| Designation |
General Manager |
| Affiliation |
TroikaaPharmaceuticals Ltd. |
| Address |
Troikaa Pharmaceuticals Ltd. Commerce House-I Satya Marg Bodakdev Ahmedabad -380054 Gujarat India
Ahmadabad
GUJARAT
380054
India |
| Phone |
7926856242 |
| Fax |
|
| Email |
vivekagarwal@troikaapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vivek Kumar Agarwal |
| Designation |
General Manager |
| Affiliation |
TroikaaPharmaceuticals Ltd. |
| Address |
Troikaa Pharmaceuticals Ltd. Commerce House-I Satya Marg Bodakdev Ahmedabad -380054 Gujarat India
Ahmadabad
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 |
Commerce House-I Satya Marg Bodakdev Ahmedabad-380054 Gujarat India |
| 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 Darshan Kharadi |
Veeda Clinical Research Ltd. |
2/A Shivalik Plaza, Dr Vikram Sarabhai Marg, near IIM, Panjara Pol, Ambawadi 380015
Ahmadabad
GUJARAT |
07967773000
07930013010
darshan.kharadi@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
|
|
|
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 50 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 β-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 dosing 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
22. Subjects who have family planning to have his own child during 06 months after the last dose of the study drug. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Plasma concentrations of Zolpidem will be measured using validated LC-MS/MS bioanalytical method
Primary variables
Cmax
AUC0-t
AUC0-inf |
Pre-dose, 2 min, 5 min, 10 min, 20 min, 30 min, 45 min and 1, 1.25, 1.5, 1.75, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10, 12 and 16 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Plasma concentrations of Zolpidem will be measured using validated LC-MS/MS
Secondary Variables
Tmax,
AUC_%Extrap_obs,
t1/2 and
Kel.
PD paramenters through Digit Symbol Substitution Test
(DSST) |
PK: Pre-dose, 2 min, 5 min, 10 min, 20 min, 30 min, 45 min and 1, 1.25, 1.5, 1.75, 2, 2.33, 2.67, 3, 3.5, 4, 5, 6, 8, 10, 12 and 16 hours
DSST: Pre dose and 6 min, 13 min, 21 min, 31 min, 40 min, 62 min after dosing ± 5 minutes of the scheduled time in each period |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/04/2022 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vivekagarwal@troikaapharma.com].
- For how long will this data be available start date provided 23-02-2022 and end date provided 23-02-2026?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Zolpidem is one of the most
popular hypnotic drugs used to treat insomnia. The drug has proved to be a
suitable and well-tolerated drug, especially with regard to efficacy in sleep
initiation. In India, there is no approved sublingual formulation of Zolpidem
available for the treatment of insomnia. Based on this fact, M/s Troikaa
Pharmaceuticals Ltd. proposed to develop a new dosage form i.e. Sublingual
Spray of Zolpidem
This bioavailability study is planned to demonstrate
comparative bioavailability, safety and tolerability of Zolpidem Tartrate
Sublingual Solution 3.85% (a dose of two sprays equivalent to 10 mg) of Troikaa
Pharmaceuticals Ltd., India with Zolfresh (Zolpidem Tartrate tablets) 10 mg of
Abbott India Limited, India in healthy, adult subjects under fasting
conditions. |