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CTRI Number  CTRI/2024/07/071202 [Registered on: 24/07/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   To assess the bioavailability of Guanfacine suspension 4 mg  
Scientific Title of Study   An Open Label Balanced Randomized Single Dose Three Treatment Three Sequence Three Period Three Way Crossover Oral Comparative Bioavailability Study Of Guanfacine For Extended Release Suspension 4 Mg Manufactured By Sciecure Pharma Inc (Subsidary Of Brillian Pharma Inc) With Intuniv (Guanfacine Hydrochloride) 4 Mg Extended Release Tablets Manufactured By Takeda Pharmaceuticals USA In Healthy Male And Female Adult Human Subjects Under Fed Conditions 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SLS-BE-0033-24-GUAN Version 01 Date 30 Mar 24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr PradeepT 
Designation  Principal Investigator 
Affiliation  Spinos life science and Research Pvt Ltd  
Address  Clinical Pharmacology Unit Ground Floor 29 A Krishna Madhuravanam Vellakinar Pirivu G N Mills

Coimbatore
TAMIL NADU
641029
India 
Phone  8220586899  
Fax    
Email  pradeep.t@spinoslifescience.com  
 
Details of Contact Person
Scientific Query  
Name  Dr PradeepT 
Designation  Principal Investigator 
Affiliation  Spinos life science and Research Pvt Ltd  
Address  Clinical Pharmacology Unit Ground Floor 29 A Krishna Madhuravanam Vellakinar Pirivu G N Mills

Coimbatore
TAMIL NADU
641029
India 
Phone  8220586899  
Fax    
Email  pradeep.t@spinoslifescience.com  
 
Details of Contact Person
Public Query  
Name  Dr PradeepT 
Designation  Principal Investigator 
Affiliation  Spinos life science and Research Pvt Ltd  
Address  Clinical Pharmacology Unit Ground Floor 29 A Krishna Madhuravanam Vellakinar Pirivu G N Mills

Coimbatore
TAMIL NADU
641029
India 
Phone  8220586899  
Fax    
Email  pradeep.t@spinoslifescience.com  
 
Source of Monetary or Material Support  
Brillian Pharma Inc 11 Deerpark Drive Suite 120 Monmouth Junction NJ 08852 USA 
Spinos Lifescience and Research Private Limited 29 A Krishna Maduravanam Vellakinar Pirivu Thudiyalur Coimbatore 641029 
 
Primary Sponsor  
Name  Sciecure Pharma Inc 
Address  11 Deerpark Dr Unit 120 Monmouth Junction NJ 08852 USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Pradeep T  Spinos Lifescience and Research Private Limited  29 A Krishna Maduravanam Vellakinar Pirivu G N Mills Post Coimbatore
Coimbatore
TAMIL NADU 		 8220586899

pradeep.t@spinoslifescience.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Fed 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Guanfacine  4 mg suspension Oral dose 3 times 
Comparator Agent  Guanfacine  4 mg suspension Oral dose 3 times 
Comparator Agent  Intuniv (Guanfacine Hydrochloride)  4 mg tablets Oral dose 3 times 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Normal healthy Male and Female adult human subjects of age between 18-45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2
Subjects who have no evidence of underlying disease during screening and check-in
Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance
Generally healthy as documented by 12-lead electrocardiogram (ECG) Chest x Ray and clinical laboratory assessments
Willing to consume non-vegetarian diet
Non- smokers
Healthy as documented by gynecological examination and breast examination
Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study and a negative urine pregnancy test prior to check-in of each period
If subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit, throughout the duration of the study and 3 weeks after the subjects last study-related visit
Childbearing potential willing to commit to using a consistent and acceptable method of birth control by double barrier method and IUD (intrauterine device)






 
 
ExclusionCriteria 
Details  Evidence of allergy or known hypersensitivity to Guanfacine or its inactive ingredients
Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease and Renal or liver impairment
Presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine or Xanthine containing products alcohol grape juice and poppy containing foods within 48 hours prior to clinic admission and throughout the entire study
History of difficulty in swallowing and inaccessibility of veins
Female subjects demonstrating a positive pregnancy and are currently lactating  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the oral bioavailability on Guanfacine for Extended-Release Suspension 4 mg  26 blood samples
00.00 hrs 00.50 hrs 01.00 hrs 01.50 hrs 02.00 hrs 02.50 hrs 03.00 hrs 03.50 hrs 04.00 hrs 04.50 hrs 05.00 hrs 05.50 hrs 06.00 hrs 06.50 hrs 07.00 hrs 07.50 hrs 08.00 hrs 09.00 hrs 10.00 hrs 12.00 hrs 16.00 hrs 24.00 hrs 36.00 hrs 48.00 hrs 72.00 hrs 96.00 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety & tolerability in healthy male & female adult human subjects under fed conditions  26 blood samples
00.00 hrs 00.50 hrs 01.00 hrs 01.50 hrs 02.00 hrs 02.50 hrs 03.00 hrs 03.50 hrs 04.00 hrs 04.50 hrs 05.00 hrs 05.50 hrs 06.00 hrs 06.50 hrs 07.00 hrs 07.50 hrs 08.00 hrs 09.00 hrs 10.00 hrs 12.00 hrs 16.00 hrs 24.00 hrs 36.00 hrs 48.00 hrs 72.00 hrs 96.00 hrs 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "17"
Final Enrollment numbers achieved (India)="17" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/08/2024 
Date of Study Completion (India) 10/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 10/09/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   Enough volunteers shall be recruited in order to evaluate and start the study with at least 18 subjects, as this Bioavailability study will be conducted on healthy, male & female, adult, human subjects.
As per the discretion of Investigator, additionally a sufficient number of stand-by subjects will be included to ensure successful dosing of 18 subjects in period I.
Demographic data, medical and medication history, physical examination, 12 lead ECG, haematology, biochemistry, serology, urine routine analysis and additionally for females serum pregnancy test, hormone assay (FSH) will be done within 21 days and chest X-ray within 06 months prior to check-in.
After collection of blood samples from all the subjects at each time point, study personnel will place the collected samples in a thermo-insulated box containing wet ice and transfer the box to the sample processing room where the blood samples will be centrifuged at 4000  50 RPM for 10 minutes at 02°C to 08°C to separate the plasma. Centrifugation will start within 30 minutes of the collection of samples, at each collection time-point. The resulting plasma will be equally transferred to pre-labeled polypropylene tubes into two aliquots.
Guanfacine in plasma will be assayed using a validated bio-analytical method.
The 90% confidence interval of the relative means of Cmax, AUC0-t and AUC0-inifinity for Guanfacine of the test and reference product should be between 80.00% and 125.00% for Ln-transformed data.
 
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