| CTRI Number |
CTRI/2023/12/060423 [Registered on: 01/12/2023] Trial Registered Prospectively |
| Last Modified On: |
29/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
study comparing test product Bilastine 3.3mg plus Dextromethorphan Hydrobromide 10mg plus Phenylephrine Hydrochloride 5mg per 5mL with reference product BilazestTM Kids (Bilastine Oral Solution 2.5mg per mL) in healthy adult human subjects under fed condition |
|
Scientific Title of Study
|
An open label, balanced, randomized, two-treatment, two-period, cross-over, oral comparative bioavailability study comparing test product, Bilastine 3.3mg + Dextromethorphan Hydrobromide 10mg + Phenylephrine Hydrochloride 5mg/5mL Syrup of Synokem Pharmaceuticals Ltd., India with reference product, BilazestTM Kids (Bilastine Oral Solution 2.5mg/mL) of Akums Drugs & Pharmaceuticals Ltd., India in healthy, adult, human subjects under fed condition |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 021-23 Version 04 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abdul Rauf Indikar |
| Designation |
MBBS (Consultant) |
| Affiliation |
Synergen Bio Pvt Ltd |
| Address |
Synergen Bio Private Limited
Unit Nos 101 to 104 Sai Chambers
302 Old Mumbai Pune Highway
Wakadewadi Shivajinagar
Pune
MAHARASHTRA
411003
India |
| Phone |
902800444 |
| Fax |
- |
| Email |
abdul.indikar@synergenbio.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neel Lahoti |
| Designation |
Director / Head CRO |
| Affiliation |
Synergen Bio PVt Ltd |
| Address |
Synergen Bio Private Limited
Unit Nos 101 to 104 Sai Chambers
302 Old Mumbai Pune Highway
Wakadewadi Shivajinagar
Pune
MAHARASHTRA
411003
India |
| Phone |
902800444 |
| Fax |
- |
| Email |
neel@synergenbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Umakant Ghodke |
| Designation |
Project Manager |
| Affiliation |
Synergen Bio PVT Ltd |
| Address |
Synergen Bio Private Limited
Unit Nos 101 to 104 Sai Chambers
302 Old Mumbai Pune Highway
Wakadewadi Shivajinagar
Pune
MAHARASHTRA
411003
India |
| Phone |
9960598942 |
| Fax |
- |
| Email |
umakantghodke@synergenbio.com |
|
|
Source of Monetary or Material Support
|
| Synokem Pharmaceuticals Ltd
14/486 Sunder Vihar
Outer Ring Road
Paschim Vihar
New Delhi 110087
India
|
|
|
Primary Sponsor
|
| Name |
Synokem Pharmaceuticals Ltd |
| Address |
14/486 Sunder Vihar Outer Ring Road Paschim Vihar New Delhi 11008 |
| 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 Neel Lahoti |
Synergen Bio Private Limited |
clinical research department
room number 101
Unit Nos 101 to 104 Sai Chambers
302 Old Mumbai Pune Highway
Wakadewadi Shivajinagar
Pune
MAHARASHTRA |
9028000444
-
neel@synergenbio.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kusum Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilastine + Dextromethorphan Hydrobromide + Phenylephrine Hydrochloride |
Bilastine
3.3mg + Dextromethorphan Hydrobromide 10mg + Phenylephrine Hydrochloride
5mg/5mL Syrup |
| Comparator Agent |
BilazestTM Kids |
Bilastine Oral Solution 2.5mg/mL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy, non-smoking, non-alcoholic human subjects (Male and/or non-pregnant,
non-lactating female) aged between 18 and 45 years (inclusive of both).
2. Female of childbearing potential must have a negative urine pregnancy test
performed within 21 days prior to initiation of the study. Female subject must have a
negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test prior to
check-in of each period. They must be using an acceptable form of contraception.
3. For female of childbearing potential, acceptable forms of contraception include the
following:
i. Non-hormonal intrauterine device in place for at least 3 months prior to the
start of the study and remaining in place during the study period and for 07
days following last dose of the study medication, or
ii. Barrier methods containing or used in conjunction with a spermicidal agent,
or
iii. Surgical sterilization or
iv. Practicing sexual abstinence throughout the course of the study
4. Female will not be considered of childbearing potential if one of the following is
reported and documented on the medical history:
i. Postmenopausal with spontaneous amenorrhea for at least one year, or
ii. Bilateral oophorectomy with or without a hysterectomy and an absence of
bleeding for at least 6 months, or
iii. Total hysterectomy and an absence of bleeding for at least 3 months.
5. Subjects with a BMI between 18.50-30.00 kg/m2
(inclusive of both) and weight not
less than 50.00 kg.
6. Subjects in normal health as determined by personal medical history, clinical
examination including vital signs and clinically acceptable results of laboratory
examinations (including serological tests).
7. Subjects having a normal or clinically not significant 12-lead electrocardiogram
(ECG) recording.
8. Subjects having a normal or clinically not significant chest X-Ray (P/A view).
9. A negative urine screen result for drugs of abuse (including amphetamines,
barbiturates, benzodiazepines, marijuana, cocaine and morphine).
10. A negative alcohol urine test or alcohol breath test result.
11. Subject able to communicate effectively and provide their informed consent.
12. Subjects willing to adhere to the protocol requirements as evidenced by informed
consent approved by ethics committee.
13. Subjects that can provide adequate evidence of their identity.
14. Availability of volunteer for the entire study duration.
15. Ability to fast for at least 10.00 hours and consume high-fat high-calorie nonvegetarian breakfast and standard meals.
16. Subject agreeing to use appropriate contraceptive measures including practice
abstention or contraception or Double Barrier method during study and 07 days after
completion of study |
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity to Bilastine and/or Dextromethorphan hydrobromide and/or
Phenylephrine hydrochloride or to related drugs or any component of this
medication.
2. Incapable of understanding the informed consent information.
3. History or presence of significant cardiovascular, pulmonary, hepatic, renal,
gastrointestinal, endocrine, immunological, dermatological, neurological or
psychiatric disease or disorder.
4. Any treatment which could bring about induction or inhibition of hepatic microsomal
enzyme system within one month of starting the study.
5. History or presence of seizure or psychiatric disorders.
6. History or presence of smoking or consumption of tobacco products.
7. History or presence of alcoholism or drug abuse.
8. History or presence of asthma, urticaria or other allergic reactions.
9. History or presence of gastric and/or duodenal ulceration.
10. History or presence of thyroid disease, adrenal dysfunction, organic intracranial
lesion.
11. History or presence of cancer.
12. Difficulty with donating blood
13. Use of any prescribed medication (including herbal remedies and vitamins) during
the two weeks before the start of the study or OTC medicinal products during one
week prior to study initiation and throughout the study.
14. Use of ketoconazole, erythromycin, diltiazem, lorazepam, monoamine oxidase
inhibitors (MAOIs), CYP2D6 inhibitors, sympathomimetic amines, beta-blockers,
other antihypertensives, tricyclic antidepressants, ergot alkaloids, digoxin and cardiac
glycosides, warfarin and other coumarins) during the two weeks before the start of
the study and throughout the study.
15. Subject consumed caffeine and/or xanthine-containing foods or beverages (i.e.
coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), grapefruit and/ or
its juice and poppy containing foods for at least 48.00 hours prior to initiation of the
study and throughout the study.
16. Major illness during the 90 days prior to check-in.
17. Participation in a drug research study within 90 days prior to check-in.
18. Donation of blood within 90 days prior to check-in.
19. Positive screening test result for any one or more of the following: HIV, Hepatitis B,
Hepatitis C and VDRL.
20. History or presence of easy bruising or bleeding.
21. Abnormal diet pattern for whatever reason (e.g. low sodium, fasting, and high
protein diets) during the four weeks preceding the study.
22. Pregnant woman and nursing mothers.
23. Female volunteer who has used implanted or injected hormonal contraceptives
anytime during the 6 months prior to study or used oral hormonal contraceptives
within 14 days before dosing.
24. Woman of child bearing age who do not agree to follow a reliable method of
contraception during study period. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of comparative bioavailability will be based on 90% confidence intervals for ratio (test/reference) of geometric least square means for Ln-transformed AUC0-t of Bilastine. |
at least 11 days from the day of check-in of the first period till the end of the second period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment the safety of the test product as compared to the reference product |
at least 11 days from the day of check-in of the first period till the end of the second period. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
11/12/2023 |
| 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="14" |
|
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
|
Study Objective: To compare the oral bioavailability of Bilastine, after three 8 hourly doses of Bilastine
3.3mg + Dextromethorphan Hydrobromide 10mg + Phenylephrine Hydrochloride
5mg/5mL Syrup of Synokem Pharmaceuticals Ltd., India (Test Product) and a single dose
of Bilazest TM Kids (Bilastine Oral Solution 2.5mg/mL) Study Design: Open-label, balanced, randomized, oral dose, two-treatment, two-sequence two-period,
crossover, comparative bioavailability study in 36 healthy, adult, human subjects under fed
condition.
study Duration: The expected duration of the study for each subject will be at least 11 days from the day of
check-in of the first period till the end of the second period. |