To study the comparative bioavailability of Guanfacine suspension in healthy adult volunteers
- Registration Number
- CTRI/2024/07/071015
- Lead Sponsor
- Brillian Pharma Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the oral bioavailability on Guanfacine For Extended-Release Suspension 4 mg with Intuniv 4.g extended release tabletsTimepoint: 26 blood samples <br/ ><br>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 Measures
Name Time Method To monitor the safety and tolerability of Gunafacine in healthy male and female adult human subjectsTimepoint: 26 blood samples <br/ ><br>00.00, 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, <br/ ><br>06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, <br/ ><br>72.00 and 96.00