To assess the bioavailability of Guanfacine suspension 4 mg

Not Applicable

• Registration Number: CTRI/2024/07/071202
• Lead Sponsor: Sciecure Pharma Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

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 mgTimepoint: 26 blood samples <br/ ><br>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 Measures

Name	Time	Method
To monitor the safety & tolerability in healthy male & female adult human subjects under fed conditionsTimepoint: 26 blood samples <br/ ><br>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