| CTRI Number |
CTRI/2024/07/071015 [Registered on: 22/07/2024] 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 study the comparative bioavailability of Guanfacine suspension in healthy adult volunteers |
|
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 Fasting Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0032-24-GUAN Version No 01 Date 30 Mar 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Private Limited |
| Address |
Clinical Pharmacology Unit
Ground Floor
29 A krishna Maduravanam
vellakinar Pirivu
G N Mills Post
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep91t@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Private Limited |
| Address |
Clinical Pharmacology Unit
Ground Floor
29 A krishna Maduravanam
vellakinar Pirivu
G N Mills Post
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep91t@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Private Limited |
| Address |
Clinical Pharmacology Unit
Ground Floor
29 A krishna Maduravanam
vellakinar Pirivu
G N Mills Post
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep91t@gmail.com |
|
|
Source of Monetary or Material Support
|
| Brillian Pharma Inc
11 Deerpark Drive
Suite 120 Monmouth Junction
NJ 08852 USA |
|
|
Primary Sponsor
|
| Name |
Brillian Pharma Inc |
| Address |
11 Deerpark Drive
Unit 120
Monmouth Junction
NJ 08852
USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Lifescience and Research Private Limited |
Clinical Pharmacology Unit
Ground Floor
29 A Krishna Maduravanam
Vellakinar Pirivu G N Mills Post
Coimbatore |
|
|
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 |
Clinical Pharmacology Unit
Ground Floor
29 A Krishna Maduravanam
Vellakinar Pirivu
G N Mills Post
Coimbatore
TAMIL NADU |
8220586899
pradeep91t@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gaunfacine ER suspension |
4 mg
Oral Dose
Three (each period one time) |
| Intervention |
Guanfacine ER suspension |
4 mg
Oral Dose
Three (each period 1 time) |
| Comparator Agent |
lntuniv ER tablets |
4 mg
Oral Dose
Three (each period one time) |
|
|
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 and whose screening is performed within 21 days of 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 Ovo lacto vegetarian diet
Willing to comply to all requirements of this study protocol as well as instructed
by the study personnel
Non Smokers
Generally healthy as documented by gynaecological examination and breast
examination
Females of childbearing potential must have a negative serum and urine pregnancy test
performed within 21 days prior to initiation of the study |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Guanfacine or its inactive ingredients
Any major illness in the last three months or any significant ongoing chronic medical illness
Renal or liver impairment
Any disease or condition which might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and or Xanthine containing products cigarettes and tobacco containing products for at least 48.00 hours prior to check-in and throughout the entire study
Subjects who have taken an unusual diet for whatever reason (eg low salt) for 48.00 hours prior to dosing and throughout the study
History of difficulty in swallowing and accessibility of veins
Positive results for urine screen of drugs of abuse and alcohol test in urine prior to check in of each period
Female subjects demonstrating a positive pregnancy screen and who 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 with Intuniv 4.g extended release tablets |
26 blood samples
00.00 hours, 00.50 hours, 01.00 hours, 01.50 hours, 02.00 hours, 02.50 hours, 03.00 hours, 03.50 hours, 04.00 hours, 04.50 hours, 05.00 hours, 05.50 hours, 06.00 hours, 06.50 hours, 07.00 hours, 07.50 hours, 08.00 hours, 09.00 hours, 10.00 hours, 12.00 hours, 16.00 hours, 24.00 hours, 36.00 hours, 48.00 hours, 72.00 hours and 96.00 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of Gunafacine in healthy male and female adult human subjects |
26 blood samples
00.00, 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50,
06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00,
72.00 and 96.00 |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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 atleast 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-bysubjects will be included to ensure successful dosing of 18 subjects in period 1. Demographic data, medical and medication history, physical examination, 12 lead ECG, haematology, biochemistry, serology, urine routine analysis and additionallyfor females serum pregnancy test, hormone assay (FSH) will be done within 21days and chest X-ray within 06 months prior to check-in. The 90% confidence interval of the relative means of Cmax, AUCo-t for Guanfacine of the test and reference product should be between 80.00% and 125.00% for Ln-transformed data |