None listed
Conditions
Interventions
Intervention1: Guanfacine: 4 mg suspension
Oral dose
3 times
Control Intervention1: Guanfacine: 4 mg suspension
Oral dose
3 times
Control Intervention2: Intuniv (Guanfacine Hydrochloride): 4 mg tablet
Sponsors
Sciecure Pharma Inc
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 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the oral bioavailability on Guanfacine for Extended-Release Suspension 4 mgTimepoint: 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
| Measure | Time frame |
|---|---|
| To monitor the safety & tolerability in healthy male & female adult human subjects under fed conditionsTimepoint: 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 | — |
Countries
India
Contacts
Public ContactDr PradeepT
Spinos life science and Research Pvt Ltd
Outcome results
None listed