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CTRI Number  CTRI/2022/04/042108 [Registered on: 25/04/2022] 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 Bilastine 20 mg and Montelukast 10 mg tablet of Signature Phytochemical Industries  
Scientific Title of Study   An Open label, balanced, randomized, two-treatment, two-sequence, two-period, single oral dose, crossover, bioequivalence study on Bilastine 20 mg and Montelukast 10 mg tablet of Signature Phytochemical Industries versus Bilasure M tablet (Bilastine 20 mg and Montelukast 10 mg) of Hetero Labs Limited in healthy adult human subjects under fasting conditions 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
ICBio/026/0821, version 00 dated 03 Aug 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priya R 
Designation  Principal investigator  
Affiliation  ICBio Clinical Research Pvt. Ltd. 
Address  #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  
Signature Phytochemical Industries Dehradun (UK)-248 011 
 
Primary Sponsor  
Name  Signature Phytochemical Industries  
Address  122 MI, Selaqui Industrial Area, Dehradun (UK)-248 011  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
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 Priya R  ICBio Clinical Research Pvt. Ltd.  #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  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adult human subjects  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bilastine 20 mg and Montelukast 10 mg tablet   Single oral dose one time during the study period for one day  
Comparator Agent  Bilasure M tablet (Bilastine 20 mg and Montelukast 10 mg)  Single oral dose one time during the study period for one day  
 
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 18-55 years (both inclusive) of age.
4.Body mass index in the range of 18 –30 kg/m2 (both inclusive)
 
 
ExclusionCriteria 
Details  1.Found Positive (+Ve) on Rapid antigen 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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cmax, AUC0-t and AUC0-∞  from day 1 to 12 
 
Secondary Outcome  
Outcome  TimePoints 
Tmax , AUC_%Extrap_obs, λz and t1/2  from day 1 to 12 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/04/2022 
Date of Study Completion (India) 06/05/2022 
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   Nil 
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 Bilastine 20 mg and Montelukast 10 mg tablet of Signature Phytochemical Industries versus Bilasure M tablet (Bilastine 20 mg and Montelukast 10 mg) of Hetero Labs Limited in healthy adult human subjects under fasting conditions.

Primary objective:

To compare rate and extend of orally administered molecule to prove bioequivalence on Bilastine 20 mg and Montelukast 10 mg tablet of Signature Phytochemical Industries versus Bilasure M tablet (Bilastine 20 mg and Montelukast 10 mg) of Hetero Labs Limited 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.

24 Subjects will be enrolled in the study . 

 
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