| CTRI Number |
CTRI/2025/04/083888 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
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 Minipress®XL GITS Tablets 5 mg of Pfizer Limited, India, in healthy human adult subjects under fasting conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 084-23-Version No:3, Final; 21MAR2024, amendment 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep Kundapur |
| Designation |
Deputy general Manager |
| Affiliation |
Ecron Acunova Limited (formerly known as Manipal Acunova Limited), |
| Address |
No. 52-2, Near Kasturba Hospital OPD Block Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9769666155 |
| Fax |
|
| Email |
pradeep.kundapur@navitaslifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ketan Asawale |
| Designation |
Medical Advisor |
| Affiliation |
Pfizer Limited |
| Address |
The Capital-A Wing, 1802,
18th Floor, Plot No. C-70, G-block, Bandra Kurla Complex, Bandra (East)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
7400477525 |
| Fax |
|
| Email |
ketan.asawale@pfizer.com |
|
Details of Contact Person
Public Query
|
| Name |
Ketan Asawale |
| Designation |
Medical Advisor |
| Affiliation |
Pfizer Limited |
| Address |
The Capital-A Wing, 1802,
18th Floor, Plot No. C-70, G-block, Bandra Kurla Complex, Bandra (East)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
7400477525 |
| Fax |
|
| Email |
ketan.asawale@pfizer.com |
|
|
Source of Monetary or Material Support
|
| Pfizer Limited,
The Capital-A Wing, 1802,
18th Floor, Plot No. C-70, G-block,
Bandra Kurla Complex, Bandra (East),
Mumbai- 400051 |
|
|
Primary Sponsor
|
| Name |
Pfizer Limited, |
| Address |
The Capital-A Wing, 1802, 18th Floor, Plot No. C-70, G-block, Bandra Kurla Complex, Bandra (East), Mumbai- 400051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep Kundapur |
Ecron Acunova Limited |
Ecron Acunova Limited (formerly known as Manipal Acunova Limited), No. 52-2, Near Kasturba Hospital OPD Block Manipal,India-576104.
Udupi
KARNATAKA |
9769666155
pradeep.kundapur@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hypertension and Benign Prostatic Hyperplasia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Prazosin Hydrochloride Minipress® XL GITS Tablets 5 mg |
After overnight fasting for at least 10.00 hours, one extended- release tablet formulation of Prazosin Hydrochloride Minipress® XL GITS Tablets 5 mg will be dosed orally to each subject while in sitting position, with 240 ± 2mL of water at room temperature, in each study period, as per randomisation schedule. The total duration of the study is expected to be at least 11 days from the check-in of the first period till end of 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 ± 2mL of water at room temperature, in each study period, as per randomisation schedule. The total duration of the study is expected to be at least 11 days from the check-in of the first period till end of second period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Normal healthy human adult volunteers aged between 18-45 years (both ages inclusive).
2. Volunteers 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. 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.
5. 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.
6. Negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR.
7. Negative test results for alcohol (in breath), negative urine drugs of abuse test.
8. Non-smoker, non-tobacco (in any form) users.
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 02 days prior to dosing, during the study & for 07 days following their last dose of IP.
14. Male subjects and/or Female subject’s partner who has not undergone vasectomy, must agree to use condoms, or spermicide in addition to female contraception for additional protection against conception during the study and for 07 days following their last dose of the study medication. |
|
| 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 mothers or are found positive in beta hCG test. 4. History of significant alcohol dependence (abuse) or drug abuse within past 1 year, current alcohol abuse or suspected abuse. 5. History of smoking, even single cigarette, bidis or any other form 6. History of asthma. 7. History of urticaria or other allergic type reactions after taking any medication. 8. History of clinically significant illness within 04 weeks before the start of the study. 9. History 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 90 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 |
| The primary objective of this study is to compare the single dose bioequivalence of Prazosin Hydrochloride Sustained Release tablets 5 mg of Pfizer Limited, India with Prazosin Hydrochloride Minipress®XL GITS Tablets 5 mg of Pfizer Pharmaceuticals LLC, USA in healthy human adult subjects under fasting conditions |
The samples for measurement of PK outcome will be drawn at baseline, third day and eleventh day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective of this study is to monitor the safety & tolerability of a single dose Prazosin Hydrochloride Sustained Release tablets 5 mg when administered in healthy human adult subjects under fasting conditions. |
Safety monitoring will be done at baseline & at each dosing day. Total duration of study is 11 days. |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="11" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 Minipress®XL GITS Tablets 5 mg of Pfizer Limited, India, in healthy human adult subjects under fasting conditions. |