To estimate the concentration of COLLISTER (Manufactured by NBI Biosciences) constituents in blood of twelve healthy adult human subjects at different time points

Not Applicable

• Registration Number: CTRI/2021/12/038703
• Lead Sponsor: BI Bioscience

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

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

Inclusion Criteria

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 (β-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

Additional tests and/or examinations may be performed, if necessary, based on Principal Investigator discretion.

All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.

Exclusion Criteria

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.

A positive hepatitis screen (includes subtypes B & C).

A positive test result for HIV antibody and / or syphilis (RPR/VDRL).

Volunteer who has received a known Investigational drug within ten elimination half-life of the administered drug prior to the first dose of study medication or have donated blood or loss of blood 50 mL to 100 mL within 30 days or 101 mL to 200 mL within 60 days or >200 mL within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.

History of difficulty in swallowing or of any gastrointestinal disease which could affect drug absorption.

Intolerance to venipuncture.

Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the volunteerâ??s participation in this study.

Institutionalized volunteers

Study & Design

• Study Type: Interventional
• Study Design: Not specified