Oral single dose Pharmacokinetic and safety study of COLLISTER Capsules 800 mg (Developed by NBI Biosciences) in twelve healthy adult human subjects

BI Bioscience0 sites0 target enrollmentStarted: TBDLast updated: February 21, 2022

Overview

No summary available.

•Male or Non\-pregnant, non\-lactating female.
•BMI: 18 to 25 weight in kg/ (height in meter) both inclusive; BMI value should be rounded off to one significant digit after decimal point
•Able to communicate effectively with study personnel.
•Able to give written informed consent to participate in the study.
•All volunteers must be judged by the principal or sub\-investigator or physician as normal and healthy during a pre\-study safety assessment performed within 28 days of the first dose of study medication.
•A physical examination with no clinically significant finding.
•Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (Î²\-HCG) pregnancy test performed within 28 days prior to the first dosing day \& prior to check\-in of each period. They must be using an acceptable form of contraception.
•Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history
•Postmenopausal with spontaneous amenorrhea for at least one year, or Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or Total hysterectomy and an absence of bleeding for at least 3 months.
•Results within normal limits or clinically non\-significant for the following tests as explained

•History of allergic responses to Prazosin or other related drugs, or any of its formulation ingredients.
•Have significant diseases or clinically significant abnormal findings during screening, \[medical history, physical examination, laboratory evaluations, ECG, chest X\-ray recording, obstetrics and gynecological history and examination (for female volunteers)].
•Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
•History or presence of bronchial asthma.
•Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
•A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
•Use of enzyme\-modifying drugs within 30 days prior to the first dose of study medication.
•History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
•Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
•History of difficulty with donating blood or difficulty in accessibility of veins.

Sponsor

BI Bioscience