None listed
Conditions
Interventions
Intervention1: Guanfacine ER suspension: 4 mg
Oral Dose
Three (each period 1 time)
Intervention2: Gaunfacine ER suspension: 4 mg
Oral Dose
Three (each period one time)
Control Intervention1: lntuniv E
Sponsors
Brillian Pharma Inc
Spinos Lifescience and Research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the oral bioavailability on Guanfacine For Extended-Release Suspension 4 mg with Intuniv 4.g extended release tabletsTimepoint: 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
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of Gunafacine in healthy male and female adult human subjectsTimepoint: 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 | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and Research Private Limited
Outcome results
None listed