| CTRI Number |
CTRI/2022/01/039667 [Registered on: 21/01/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study on BILSYN – M tablet (Bilastine 20 mg and Montelukast 10 mg) in healthy adult human subjects under fasting conditions |
|
Scientific Title of Study
|
An Open label, balanced, randomized, two-treatment, two-sequence, two-period, single oral dose, crossover, bioequivalence study on BILSYN – M tablet (Bilastine 20 mg and Montelukast 10 mg) of SYNMEDIC Laboratories versus Bilazap® M tablet (Bilastine 20 mg and Montelukast 10 mg) of Glenmark Pharmaceuticals Ltd., in healthy adult human subjects under fasting conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/006/0321 version 01, dated 27 Oct 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kadiyala Venkata Sahitya |
| Designation |
Principal investigator |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
Second floor room no:2
#16&18 ICBio Tower
Yelahanka Main Road
Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
pi.mail@icbiocro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Operation Director |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16&18 ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Operation Director |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16&18 ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| SYNMEDIC Laboratories
SP-3-5 A and C, RIICO Industrial Area, Keshwana, Kotputli, Jaipur, Rajasthan-303108 |
|
|
Primary Sponsor
|
| Name |
SYNMEDIC Laboratories |
| Address |
SP-3-5 A and C, RIICO Industrial Area, Keshwana, Kotputli, Jaipur Rajasthan-303108 |
| 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 Kadiyala Venkata Sahitya |
ICBio Clinical Research Pvt. Ltd. |
Second floor room no:2 , Clinica; departament #16 &18 ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA |
9900111997
pi.mail@icbiocro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male and female subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bilazap® M tablet |
single dose of (Bilastine 20 mg and Montelukast 10 mg) one time only. |
| Intervention |
BILSYN – M tablet |
Single dose of (Bilastine 20 mg and Montelukast 10 mg) one time only. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
2. Willing to be available for the entire study period and to comply with protocol requirements.
3. Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
4. Body mass index in the range of 18 –25 kg/m2 (both inclusive).
5. Normal haemoglobin between 12.5 to 17.5 grams per deciliter (g/dL) for men and 12.0 to 16.0 g/dL for female.
6. Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period.
7. With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis (included in section no. 9.1).
8. With a normal or clinically non-significant 12-lead ECG.
9. With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies
|
|
| ExclusionCriteria |
| Details |
1. Found +ve PCR test for COVID-19 during screening.
2. Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women.
3. Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs.
4. History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
5. History of severe infection or major surgery in the past 6 months.
6. History of Minor surgery or fracture within the past 3 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare rate and extend of orally administered molecule to prove bioequivalence on BILSYN – M tablet (Bilastine 20 mg and Montelukast 10 mg) of SYNMEDIC Laboratories versus Bilazap® M tablet (Bilastine 20 mg and Montelukast 10 mg) of Glenmark Pharmaceuticals Ltd., in healthy adult human subjects under fasting conditions. |
Day 1 to Day 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety of the study subjects after administration of Bilastine and Montelukast in healthy adult human subjects under fasting conditions. |
Day 1 to Day 12 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/01/2022 |
| Date of Study Completion (India) |
11/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="12" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An Open label,
balanced, randomized, two-treatment, two-sequence, two-period, single oral
dose, crossover, bioequivalence study on BILSYN – M tablet (Bilastine 20 mg and
Montelukast 10 mg) of SYNMEDIC Laboratories versus Bilazap® M tablet (Bilastine 20 mg and Montelukast 10 mg) of Glenmark Pharmaceuticals Ltd., in healthy adult
human subjects under fasting conditions.
24 Subjects will be enrolled in the study.
The study objective Primary objective: To compare rate
and extend of orally administered molecule to prove bioequivalence on BILSYN –
M tablet (Bilastine
20 mg and Montelukast 10 mg) of SYNMEDIC Laboratories versus Bilazap® M tablet (Bilastine 20 mg and
Montelukast 10 mg) of Glenmark Pharmaceuticals
Ltd., in healthy adult human subjects under fasting conditions.
Secondary objective:
To monitor the safety of the study subjects
after administration of Bilastine 20 mg and
Montelukast 10 mg tablet in healthy adult human subjects under fasting
conditions. |