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CTRI Number  CTRI/2022/06/043281 [Registered on: 15/06/2022] Trial Registered Prospectively
Last Modified On: 07/06/2022
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Other 
Public Title of Study   A bioequivalence study of Prazosin Hydrochloride tablets 5 mg in healthy human adult subjects under fasting conditions  
Scientific Title of Study   A randomized, open label, balanced, two treatment, two period, two sequence, cross over, single dose bioequivalence study of Prazosin Hydrochloride Sustained Release tablets 5 mg of Pfizer Limited, India comparing with PRAZOSIN HYDROCHLORIDE GITS TABLETS MINIPRESS®XL GITS Tablets 5 mg of Pfizer Limited, India, in healthy human adult subjects under fasting conditions 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No. 018-22, Version-1, Final; Date: 16.03.2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjula Shetty 
Designation  Principal Investigator 
Affiliation  Ecron Acunova Limited (Formerly known as Manipal Acunova Limited), 
Address  IV floor, Sri Shirdi Sai Baba Cancer Hospital & Research Centre, Manipal

Udupi
KARNATAKA
576 104
India 
Phone  91-9591803699  
Fax    
Email  manjula.shetty@navitaslifesciences.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Charles V Adhav 
Designation  Medical Lead 
Affiliation  Pfizer Limited 
Address  Pfizer Limited, The Capital, 1802/1901, Plot No. C 70, G Block, Bandra Kurla Complex, Bandra(E)

Mumbai
MAHARASHTRA
400051
India 
Phone  91-918879974170  
Fax    
Email  charles.adhav@pfizer.com  
 
Details of Contact Person
Public Query  
Name  Dr Charles V Adhav 
Designation  Medical Lead 
Affiliation  Pfizer Limited 
Address  Pfizer Limited, The Capital, 1802/1901, Plot No. C 70, G Block, Bandra Kurla Complex, Bandra(E)

Mumbai
MAHARASHTRA
400051
India 
Phone  91-918879974170  
Fax    
Email  charles.adhav@pfizer.com  
 
Source of Monetary or Material Support  
Pfizer Limited, The Capital, The Capital-A Wing, 1802, 18th Floor, Plot No. C 70, G Block, Bandra Kurla Complex, Bandra(E), Mumbai-400051, Maharashtra, India 
 
Primary Sponsor  
Name  Pfizer Limited 
Address  The Capital, The Capital-A Wing, 1802, 18th Floor, Plot No. C 70, G Block, Bandra Kurla Complex, Bandra(E), Mumbai-400051, Maharashtra, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjula Shetty  M/s Ecron Acunova Limited  IV floor, Sri Shirdi Sai Baba Cancer Hospital & Research Centre, Manipal- 576 104
Udupi
KARNATAKA 		 91-9591803699

manjula.shetty@navitaslifesciences.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manipal Academy of Higher Education (MAHE) Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hypertension and Benign Hyperplasia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PRAZOSIN HYDROCHLORIDE GITS TABLETS MINIPRESS®XL GITS Tablets 5 mg  After overnight fasting for at least 10.00 hours, one extended-release tablet formulation of PRAZOSIN HYDROCHLORIDE GITS TABLETS MINIPRESS®XL GITS Tablets 5 mg will be dosed orally to each subject while in sitting position, with 240 ± 2 mL of water at room temperature, in each study period, as per the randomization schedule. The total duration of the study is expected to be at least 10 days from the check-in of first period till the end of the second period. 
Intervention  Prazosin Hydrochloride Sustained Release tablets 5 mg  After overnight fasting for at least 10.00 hours, one extended-release tablet formulation of Prazosin Hydrochloride Sustained Release tablets 5 mg will be dosed orally to each subject while in sitting position, with 240 ± 2 mL of water at room temperature, in each study period, as per the randomization schedule. The total duration of the study is expected to be at least 10 days from the check-in of first period till the end of the second period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Normal healthy human adult male and/or female volunteers aged between 18-45 years (both ages inclusive).
2. Volunteer provided written informed consent and are willing to participate in the study.
3. Volunteer with Body Mass Index of 18.50 to 30.00 Kg/m2 (both inclusive).
4. A total body weight >50 kg (110 lb).
5. No evidence of underlying disease during pre-study screening, medical history, physical examination and laboratory investigations done within 21 days prior to commencement of the study.
6. Pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to participation in the study.
7. Negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR.
8. Negative test results for alcohol (in urine), negative urine drugs of abuse test.
9. 12 lead ECG recording either normal or within acceptable limits or considered by the Investigator to be of no clinical significance with respect to his/her participation in the study.
10. Normal or clinically non - significant chest X-ray (PA) taken within 06 months before the day of dosing.
11. Available for the entire study and capable of understanding instructions and communicating with the investigators and clinical study facility staff.
12. Female volunteers who is having negative results in urine pregnancy test during screening and Beta hCG-test at the time of check-in.
13. Females with child-bearing potential must agree to use an acceptable method of contraception at least 2 days prior to dosing, during the study & for 07 days following their last dose of IP.
14. Male volunteers and/or female volunteer’s partner must agree to use condoms, vasectomy or spermicide in addition to female contraception for additional protection against conception throughout the study & for 07 days following their last dose of IP. 
 
ExclusionCriteria 
Details  1. Known allergy to PRAZOSIN HYDROCHLORIDE or any component of the formulation and to any other related drug.
2. History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
3. Female volunteers who are nursing motherslactating women or are found positive in beta hCG test.
4. History/presence of significant alcohol dependence (abuse) or drug abuse within past 1 year, current alcohol abuse (greater 5 units/week, 1 unit equal to 10 mL or 8 g of pure alcohol) or suspected abuse.
5. Who is every day smoker (who has smoked at least 100 cigarettes in his or her lifetime, and who now smokes every day) or consumption of tobacco products.
6. History/presence of asthma.
7. History/presence of urticaria or other allergic type reactions after taking any medication.
8. History/presence of clinically significant illness within 04 weeks before the start of the study.
9. History/presence of significant Hypersensitivity to heparin.
10. History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs.
11. Scheduled for surgery any time during study or within 07 days after study completion.
12. History of difficulty in donating blood.
13. With unsuitable veins for repeated venipuncture.
14. Participation in any other clinical or bioequivalence study or otherwise would have donated in excess of 350 mL of blood in the last 90 days.
15. Consumption of prescription medication or OTC products (including vitamins and natural products) within 14 days prior to dosing in Period 1, including topical medication.
16. Hospitalization within 28 days prior to administration of the study medication.
17. History of difficulty in swallowing.
18. Evidence of skin lesions on forearm of signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial.
19. With Systolic blood pressure less than 100 mm of Hg or more than 140 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator.
20. With Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cmax, AUC0-t and AUC0-∞ of prazosin  Assessed after dosing at 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00 and 16.00 hours and during each ambulatory visit in each study period. 
 
Secondary Outcome  
Outcome  TimePoints 
tmax, t½ and Kel of prazosin.

Adverse events (AEs). 		 Assessed after dosing at 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00 and 16.00 hours and during each ambulatory visit in each study period. 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/06/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A randomized, open label, balanced, two treatment, two period, two sequence, cross over, single dose bioequivalence study of Prazosin Hydrochloride Sustained Release tablets 5 mg of Pfizer Limited, India comparing with PRAZOSIN HYDROCHLORIDE GITS TABLETS MINIPRESS®XL GITS Tablets 5 mg of Pfizer Limited, India, in healthy human adult subjects under fasting conditions. 
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